Paulness
2週前
NEWS -- bioAffinity Technologies Reports Positive Preclinical Findings Showing Proprietary Gene Silencing Technology Is Selectively Cytotoxic to Squamous Skin Cancer Cells Without Harming Healthy Cells
Research suggests a potential topical treatment for common skin cancers, squamous cell and basal cell carcinoma
Findings will be presented at 2026 RNA Therapeutics Symposium June 24-26bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics and targeted therapeutics, will present preclinical findings for a novel therapeutic approach that uses small interfering RNAs (siRNAs) that kill squamous and basal skin cancer cells in vitro while leaving non-cancerous skin cells unharmed.
The newly released findings support the Company’s efforts to develop topical treatments for squamous cell and basal cell carcinoma, two of the most common forms of skin cancer. An estimated 5.4 million cases of these skin cancers are diagnosed every year in the U.S., according to the American Cancer Society. Although surgery is the standard treatment, many patients require additional intervention because of incomplete resection, in which all of the cancerous tissue is not removed, or the risk of recurrence. To date, there is no commercial topical siRNA therapy specifically indicated for basal cell or squamous cell carcinoma.
David J. Elzi, PhD, bioAffinity Technologies Vice President of Product Development, will present the Company’s research at the 2026 RNA Therapeutics (RNATx) Symposium. RNATx brings together researchers, biotech/pharma, clinicians and industry focused on RNA therapeutics, oligonucleotides, mRNA, siRNA, gene editing and translational medicine.
“Basal cell and cutaneous squamous cell carcinomas are among the most common cancers we treat,” said surgical oncologist Rosa Cuenca, MD, who is not affiliated with bioAffinity Technologies. “Unfortunately, surgical removal is not always the end of the story. A topical therapeutic that selectively targets malignant cells while preserving healthy skin could potentially expand our treatment options, particularly for patients with recurrent lesions or cosmetically sensitive tumors."
The research builds on earlier findings showing that siRNA silencing of two specific cell surface receptors, CD320 and LRP2, impaired cell viability across multiple cancer cell lines in vitro – including lung, breast, prostate, brain, and skin cancer – while sparing healthy primary cells. That discovery is the subject of U.S. Patent No. 12,305,171, “Compositions and Methods for Treating Cancer,” issued in 2025.
“Our in vitro findings indicate that silencing specific cell surface receptors was selectively cytotoxic to or impaired the proliferation of squamous skin cancer cells while leaving normal skin cells unaffected,” Dr. Elzi said. “The selectivity observed in these preclinical studies suggests the potential for further development of noninvasive, targeted topical approaches for common cutaneous cancers, subject to further research and regulatory review.”
“Our preclinical results represent an encouraging step toward developing less-invasive treatments for some of the most common cancers affecting patients today,” said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. “This research reinforces our innovative approach to cancer treatments and expands our mission to improve cancer outcomes by developing technologies designed to detect and treat cancer earlier and more precisely.”
In the in vitro study, researchers synthesized siRNAs targeting specific cell receptors and transfected them into squamous and basal skin cancer cell lines and non-cancerous skin cells. Non-cancerous skin cells were unaffected by silencing the receptors, while squamous and basal skin cancer cell proliferation was significantly impaired. Microscopic analysis corroborated these findings, demonstrating cancer cell cytotoxicity following treatment without observable harm to healthy cells. These results were obtained in controlled laboratory conditions and may not be predictive of results in human clinical trials. The Company’s preclinical findings have not been tested in humans, and no Investigational New Drug (IND) application has been filed with the U.S. Food and Drug Administration (FDA).
About the Research
The poster, “siRNAs targeting CD320 and LRP2 are selectively cytotoxic to squamous skin cancer cells while leaving normal skin cells unharmed,” will be presented at RNATx 2026 June 24-26 hosted by the RNA Therapeutics Institute at UMass Chan Medical School in Worcester, MA.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the early stage of the Company's siRNA therapeutic research and the uncertainty of preclinical in vitro results, the risk that preclinical results may not be replicated in animal studies or human clinical trials, the Company's ability to obtain regulatory approvals including IND authorization from the FDA, the Company's ability to secure sufficient funding to advance its research and development programs, risks related to the Company's intellectual property, the competitive landscape for RNA therapeutics and cancer diagnostics, the Company's limited operating history with respect to therapeutic development, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260622115344/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
US Market News
2週前
bioAffinity Technologies Announces Closing of $3.2 Million OfferingJune 18, 2026 1:16 PM
Business WirebioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW),a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today announced the closing of its previously announced public offering of securities as described below for aggregate gross proceeds to the Company of $3.2 million, before deducting agent fees and other estimated expenses payable by the company.The offering consisted of 4,000,000 shares of its common stock, par value $0.007 per share (or pre-funded warrants in lieu thereof) at a purchase price of $0.80 per share (or $0.793 per pre-funded warrant). Each pre-funded warrant will be exercisable for one share of common stock and will be immediately exercisable and will expire when exercised in full.The closing of the offering is expected to occur on or about June 18, 2026, subject to the satisfaction of customary closing conditions.WallachBeth Capital, LLC acted as sole placement agent for the offering.The securities described above were offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-296764), as amended, previously filed and declared effective by the Securities and Exchange Commission (the “SEC”). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering was made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at cap-mkts @shavach, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.About CyPath® LungCyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.About bioAffinity Technologies, Inc.bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to close the offering when anticipated and the risk factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.View source version on businesswire.com: https://www.businesswire.com/news/home/20260618108310/en/bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com Original: bioAffinity Technologies Announces Closing of $3.2 Million Offering
US Market News
3週前
WallachBeth Capital Announces Pricing of bioAffinity Technologies $3.2 Million OfferingJune 17, 2026 10:41 AM
PR Newswire (US) JERSEY CITY, N.J., June 17, 2026 /PRNewswire/ -- WallachBeth Capital LLC, a leading provider of capital markets and institutional execution services, announced today that bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, priced a Public Offering of securities as described below for aggregate gross proceeds to the Company of $3.2 million, before deducting agent fees and other estimated expenses payable by the company. The offering consists of 4,000,000 shares of its common stock, par value $0.007 per share (or pre-funded warrants in lieu thereof) at a purchase price of $0.80 per share (or $0.793 per pre-funded warrant). Each pre-funded warrant will be exercisable for one share of common stock and will be immediately exercisable and will expire when exercised in full.The closing of the offering is expected to occur on or about June 18, 2026, subject to the satisfaction of customary closing conditions.WallachBeth Capital, LLC is acting as sole placement agent for the offering.The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-296764), as amended, previously filed and declared effective by the Securities and Exchange Commission (the "SEC"). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering is being made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at cap-mkts @shavach, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA.About WallachBeth Capital LLC:WallachBeth Capital offers a robust range of capital markets and investment banking services to the healthcare community, connecting corporate clients with leading institutions, supporting issuers and investors in achieving their financial goals. The firm's experience includes initial public offerings, follow-on issues, PIPE offerings, and private transactions and ATM's.Forward-Looking StatementsCertain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to close the offering when anticipated and the risk factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View original content:https://www.prnewswire.com/news-releases/wallachbeth-capital-announces-pricing-of-bioaffinity-technologies-3-2-million-offering-302803249.htmlSOURCE WallachBeth Capital LLC Original: WallachBeth Capital Announces Pricing of bioAffinity Technologies $3.2 Million Offering
US Market News
3週前
bioAffinity Technologies Announces Pricing of $3.2 Million OfferingJune 17, 2026 9:25 AM
Business Wire bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today announced that it has priced a Public Offering of securities as described below for aggregate gross proceeds to the Company of $3.2 million, before deducting agent fees and other estimated expenses payable by the company. The offering consists of 4,000,000 shares of its common stock, par value $0.007 per share (or pre-funded warrants in lieu thereof) at a purchase price of $0.80 per share (or $0.793 per pre-funded warrant). Each pre-funded warrant will be exercisable for one share of common stock and will be immediately exercisable and will expire when exercised in full. The closing of the offering is expected to occur on or about June 18, 2026, subject to the satisfaction of customary closing conditions. WallachBeth Capital, LLC is acting as sole placement agent for the offering. The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-296764), as amended, previously filed and declared effective by the Securities and Exchange Commission (the “SEC”). This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering is being made only by means of a preliminary prospectus and final prospectus that will form a part of the registration statement. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplements may be obtained, when available, from WallachBeth Capital, LLC, via email at cap-mkts @shavach, or by standard mail at WallachBeth Capital LLC, Attn: Capital Markets, 185 Hudson St., Suite 1410, Jersey City, NJ 07311, USA. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to close the offering when anticipated and the risk factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260617929210/en/ bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com Original: bioAffinity Technologies Announces Pricing of $3.2 Million Offering
US Market News
3週前
bioAffinity Technologies Announces Program to Advance Veteran Lung Health: Philips, bioAffinity Technologies and 4DMedical Highlight New Approaches to Lung Health Screening for U.S. VeteransJune 16, 2026 8:06 AM
Business Wire Expert panel will share real-world case studies to demonstrate how mobile CT screening, noninvasive CyPath® Lung testing, and comprehensive functional lung imaging can reduce cost while improving access, early detection and outcomes for veterans National Association of Veterans’ Research and Education Foundations (NAVREF) to host July 21 webinar Register here bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing cancer diagnostics including CyPath® Lung, the Company’s commercially available test for early-stage lung cancer, announced a webinar on July 21, 2026, featuring clinical experts discussing emerging approaches to lung health screening and early detection for veterans at increased risk for lung cancer and other respiratory diseases. The educational webinar will explore current challenges in identifying and managing lung disease in veteran populations, including those potentially impacted by toxic exposures recognized under the PACT Act. Presenters will discuss advances in diagnostic technologies, imaging capabilities, and strategies that may support earlier detection and improved clinical decision-making. The webinar will feature clinical perspectives on: Lung cancer risk among veterans and the importance of early detection The evolving role of imaging in lung health assessment Emerging noninvasive diagnostic approaches Opportunities to improve patient access to screening and follow-up care Considerations for implementing comprehensive lung health programs Speakers: Moderator Rashi Romanoff, Chief Executive Officer, National Association of Veterans’ Research and Education Foundations (NAVREF) NAVREF is a nonprofit organization that supports the research and education mission of the Department of Veterans Affairs by advancing innovation, fostering public-private partnerships, and accelerating the development of new healthcare solutions for veterans. NAVREF serves as a bridge between VA researchers, industry, academia, and philanthropic organizations to help bring promising technologies and clinical advancements to the veteran community. Panelists Amy Rohs, MD, is a board-certified physician in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine with more than 20 years of clinical experience and over a decade of leadership in tele-critical care, virtual health, and healthcare innovation. A former VA clinical and operational leader and current Physician Clinical Champion with Philips, she combines extensive experience in critical care, telemedicine, and military medicine to advance scalable, technology-enabled models of care. Philips is a health technology company focused on improving people’s lives through meaningful innovation – from healthy living and prevention to diagnosis, treatment and home care. Applying advanced technologies and deep clinical and consumer insights, Philips partners with customers to deliver integrated solutions that help provide improved patient experience, better health outcomes, improved staff experience, and lower cost of care. Michael Nicholson, DO, will discuss his clinical experience using CyPath® Lung, bioAffinity Technologies’ noninvasive test for early detection of lung cancer. He is a pulmonary, critical care, advanced lung disease, and lung transplantation specialist whose clinical focus includes improving noninvasive malignancy risk stratification for patients with pulmonary nodules. Dr. Nicholson has published peer-reviewed research, presented at international conferences, and authored textbook chapters on topics including bronchoscopic lung volume reduction, COPD, alpha-1 antitrypsin deficiency, interstitial lung disease, pulmonary hypertension, lung transplantation, and pleural disease. Dr. Nicholson practices at RWJBarnabas Health, New Jersey’s largest and most comprehensive academic health system, providing integrated care, medical education, and research across a statewide network of hospitals, ambulatory centers, and specialty practices. CyPath® Lung is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Greg Mogel, MD, 4DMedical’s Chief Medical Officer, is a practicing radiologist and physician executive with a long career in medicine and engineering in government, academia, and industry. He previously held multiple leadership roles at Kaiser Permanente where he played a central role in the establishment of Lung Cancer Screening across the largest integrated healthcare delivery system in the United States. A proud veteran, Greg served in the United States Army Medical Corps. 4DMedical Limited is a medical technology company that develops advanced imaging and analysis solutions to assess lung structure and function. Its proprietary platform provides clinicians with highly detailed, noninvasive visualization of lung motion and airflow, enabling earlier detection of respiratory diseases and improved patient management. Event Details:
Date: July 21, 2026
Time: 6 p.m. ET/5:00 p.m. CT (US and Canada) Veterans experience a higher incidence of lung cancer than the general population, underscoring the importance of timely screening and diagnostic evaluation. The webinar will provide healthcare professionals with insights into current clinical practices and emerging technologies that may help support improved outcomes for at-risk patients. The program is intended for healthcare professionals involved in pulmonary medicine, oncology, radiology, primary care, veteran health services, and related specialties. For additional information or to register, please click this link. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to successfully commercialize CyPath® Lung, risks related to the regulatory environment for laboratory developed tests, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260616548672/en/ bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com Original: bioAffinity Technologies Announces Program to Advance Veteran Lung Health: Philips, bioAffinity Technologies and 4DMedical Highlight New Approaches to Lung Health Screening for U.S. Veterans
Paulness
1月前
NEWS -- Multidisciplinary Physician Panel to Share Real-World Benefits of bioAffinity Technologies’ Noninvasive CyPath Lung Cancer Test in Upcoming Society for Advanced Bronchoscopy Webinar
Interventional pulmonologist, medical oncologist and thoracic surgeon will discuss how CyPath® Lung results have made a critical difference in their practices
CyPath® Lung has demonstrated the ability to aid in the detection of early-stage lung cancer and support surveillance of cancer survivors for recurrence
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today announced the Society for Advanced Bronchoscopy (SAB) will host a webinar on CyPath® Lung’s expanding role in pulmonary, oncology and surgical practices for the detection and management of early-stage lung cancer.
The live webinar, “Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath® Lung Testing,” will take place Tuesday, June 16, at 7 p.m. ET. Clinicians, pulmonologists, oncologists, thoracic surgeons, healthcare professionals and the public are invited to register here (https://bit.ly/3PaFPSR) for the complimentary education event.
“We are seeing a significant increase in patients with indeterminate lung nodules as a result of expanded lung cancer screening and imaging for other conditions. When we consider not only prior smoking history but also an aging population, environmental and occupational exposures, and a better understanding of genetic predispositions, we recognize the real clinical challenges of managing this condition, of distinguishing between malignant and benign nodules,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.
“Advanced navigational bronchoscopy serves as an accurate tool to diagnose lung cancer without major surgery, particularly in nodules greater than a centimeter. For smaller nodules, CyPath® Lung complements bronchoscopy by helping to risk stratify and identify patients who should move forward with more invasive follow-up,” Dr. Downie said.
Moderated by pulmonologist Robert Sussman, MD, former Medical Director of the Atlantic Health System Pulmonary Clinical Research Center, the webinar will feature:
Vijay K. Gunuganti, MD – Medical oncologist and hematologist at Texas Oncology
Reginald Carl Baptiste, MD – Thoracic and cardiovascular surgeon at Christus St. Michael Health System
Sai Karan Vamsi Guda, DO – Director of Interventional Pulmonary at Texas Pulmonary and Critical Care Consultants, P.A.The panel will discuss how CyPath® Lung, a noninvasive test that uses automated flow cytometry and artificial intelligence to analyze the lung microenvironment, is being incorporated into their practice to help:
aid in the detection of lung cancer at its earliest and most treatable stages
support surgical and treatment decision-making
lower overall healthcare costs by reducing unnecessary invasive procedures
support surveillance of cancer patients after they complete treatment.“We are honored to collaborate with the Society for Advanced Bronchoscopy to provide clinicians with an opportunity to discuss innovative tools like CyPath® Lung that support earlier intervention leading to better patient outcomes,” said Maria Zannes, President and CEO of bioAffinity Technologies.
About the Society for Advanced Bronchoscopy
The Society for Advanced Bronchoscopy (SAB) is a national organization dedicated to advancing the field of bronchoscopy through innovation, collaboration and education. Founded to improve patient outcomes, SAB fosters excellence in interpretive skills, technical knowledge, research, and training for advanced bronchoscopic techniques. The society unites a multidisciplinary community – including physicians, advanced practice providers, respiratory therapists, and technologists – to push the boundaries of minimally invasive lung diagnostics and interventions, ultimately transforming the standard of care and enhancing the diagnosis and treatment of respiratory diseases worldwide.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to successfully commercialize CyPath® Lung, risks related to the regulatory environment for laboratory developed tests, the Company's ability to obtain and maintain adequate reimbursement for its products, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260602109596/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
Paulness
1月前
NEWS -- bioAffinity Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath® Lung Technology
Strong intellectual property portfolio helps build shareholder value
Patent strategy protects CyPath® Lung’s flow cytometry-driven diagnostic approach in international markets
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath® Lung, the Company’s commercially available test for early-stage lung cancer, today announced it has received notification of allowance from the Mexican Institute of Industrial Property for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.
Upon issuance, the Mexican patent application will protect the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.
“This patent expands our global intellectual property portfolio and protection of CyPath® Lung’s proprietary approach to detecting lung cancer at its earliest and most treatable stages,” said Maria Zannes, President and CEO of bioAffinity Technologies. “The integration of advanced cell biology, flow cytometry and AI into an easy-to-use, noninvasive test clearly differentiates our technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients.”
CyPath® Lung uses flow cytometry and artificial intelligence with at-home sample collection to assess indeterminate pulmonary nodules in high-risk patients. Physicians are adding CyPath® Lung to the clinical pathway to help risk stratify patients, reduce patient anxiety, support surgical and treatment decision-making, and reduce overall healthcare costs.
The patent further strengthens the Company’s intellectual property (IP) portfolio supporting its flow cytometry-based CyPath® Lung diagnostic platform, which now includes multiple patents in the United States, the European Union, China, Japan, Australia, Canada and Mexico. “Strong intellectual property protection for CyPath® Lung benefits not only patients and their physicians, but also supports value creation for our shareholders,” Ms. Zannes said.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the risk that pending patent applications may not result in issued patents, changes in the regulatory framework governing Laboratory Developed Tests including potential increased FDA oversight, the Company's ability to successfully commercialize CyPath® Lung in domestic and international markets, the Company's ability to realize value from its international intellectual property portfolio, the sufficiency of the Company's capital resources, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260527333514/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
US Market News
2月前
bioAffinity Technologies Reports Record Monthly CyPath® Lung Unit Sales and Significant Year-Over-Year Growth in April 2026May 12, 2026 9:15 AM
Business Wire CyPath® Lung unit sales in April increased nearly 300% compared to April 2025 Increasing unit sales for CyPath® Lung continues first quarter 2026 trend of accelerating adoption and clinical use Noninvasive test has potential to transform lung cancer risk assessment and nodule management bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced that unit sales for its CyPath® Lung diagnostic test achieved a record high in a single month and increased nearly 300% in April 2026 compared to the same period in 2025, based on preliminary unaudited data. The strong CyPath® Lung unit sales growth so far this year continues to exceed the Company’s internal projections and reflects accelerating physician adoption and expanding clinical use by physicians using the Company’s noninvasive test to aid in diagnosing lung cancer. “The growth in CyPath® Lung usage continues to accelerate at a rapid pace as the value of our novel lung cancer diagnostic is increasingly being recognized,” said Maria Zannes, President and CEO of bioAffinity Technologies. “CyPath® Lung addresses a significant gap in the diagnostic pathway by supporting lung cancer risk stratification and pulmonary nodule management as physicians seek more accurate, noninvasive tools to assess cancer risk and detect disease at its earliest, most treatable stage. We are very pleased with the unit growth that we delivered in April, and we remain focused on expanding adoption of CyPath® Lung to aid physicians in the early detection of lung cancer and pulmonary nodule management.” Addressing a Large and Growing Clinical Need The number of patients identified with indeterminate pulmonary nodules continues to rise, driven in part by increases in incidental findings and screening by low-dose CT for high-risk patients. This expanding patient population poses a diagnostic challenge for physicians who have to weigh the benefits and risks of “watchful waiting” versus invasive procedures like biopsy. CyPath® Lung’s flow cytometry+AI technology provides actionable information to support clinical decision-making by the ordering physician. The test result is intended to be used in conjunction with other clinical information and is not a standalone diagnostic. Real-world patient cases have demonstrated the test’s ability to: Help detect lung cancer at Stage 1A, when it is most treatable Help avoid unnecessary invasive, risky, and costly procedures when the test result is negative Executing a Focused Commercial Strategy bioAffinity Technologies has prioritized CyPath® Lung as its core commercial focus, aligning resources to accelerate adoption and scale. Growth has been driven by: Expansion of ordering physician sites Increased peer-to-peer education among pulmonologists Integration of CyPath® Lung into clinical workflows for lung cancer risk assessment and nodule management Positioned for Continued Expansion The company is advancing multiple initiatives to further expand the clinical impact of its proprietary technology platform, including: A large-scale longitudinal clinical study designed to generate additional validation data for CyPath® Lung Broader use of CyPath® Lung to monitor lung cancer survivors after treatment An R&D pipeline that includes diagnostic tests for asthma and COPD that will help guide personalized treatment with targeted therapies. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to maintain and grow CyPath® Lung unit volume, the Company's ability to achieve or maintain profitability, the Company's dependence on a single commercial product, risks related to the regulatory environment for laboratory developed tests, the Company's ability to obtain adequate reimbursement coverage for CyPath® Lung, the Company's ability to successfully execute its commercial strategy and expand its customer base, the outcome of ongoing and future clinical studies, and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512770887/en/ bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com Original: bioAffinity Technologies Reports Record Monthly CyPath® Lung Unit Sales and Significant Year-Over-Year Growth in April 2026
US Market News
2月前
bioAffinity Technologies Reports First Quarter 2026 Results and Expanding Adoption and Clinical Usage of CyPath® LungMay 8, 2026 8:30 AM
Business Wire CyPath® Lung cancer diagnostic unit sales rise 146% year-over-year Growth expected to accelerate throughout 2026 as planned commercial initiatives seek to drive increasing awareness of CyPath® Lung benefits bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the first quarter ended March 31, 2026. Q1 2026 Highlights CyPath® Lung unit sales increased 146% year-over-year in the first quarter of 2026, reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive lung cancer diagnostic. CyPath® Lung testing revenue increased approximately 114% to $361,000, compared to $169,000 in the first quarter of 2025. Total consolidated revenue decreased approximately 27% to $1.4 million, compared to $1.9 million for the first quarter of 2025, resulting from the discontinuation of certain unprofitable pathology services in March 2025 to focus on higher margin services, including CyPath® Lung testing. The number of physician offices and clinics ordering CyPath® Lung increased 69% from first quarter 2025 to the same period in 2026, reflecting continued productivity and expansion of the Company’ sales force and focus on additional strategic markets. The Company expects growth to accelerate throughout 2026, as a result of these commercial initiatives and increasing awareness of the benefits of CyPath® Lung. The Company launched a large-scale longitudinal clinical trial partially funded by the U.S. Department of Defense to further validate CyPath® Lung performance and support establishing the noninvasive test as a standard of care for military and Veterans Administration (VA) medical centers. The trial is expected to include up to 20 clinical sites, including multiple Department of Veterans Affairs medical centers and leading U.S. military hospitals. The John P. Murtha Cancer Center Research Program is providing support and funding for the study at several federal facilities. As part of the Company’s commercial strategy to develop companion tests using its diagnostic platform to more precisely target drugs that treat asthma and COPD, bioAffinity Technologies announced that Brooke Army Medical Center, the military’s largest healthcare institution, was conducting a 40-patient collaborative study. The study will use bioAffinity Technologies’ flow cytometry+AI technology to evaluate whether its proprietary platform can detect biologic drug receptors in sputum, including those for dupilumab and benralizumab, to guide personalized therapy selection and monitor patient response over time. The Company presented findings from its early pipeline development activities at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting. Nationally recognized pulmonary and lung cancer experts joined the Company’s Medical and Scientific Advisory Board (MSAB) to provide independent guidance on strategic priorities, including clinical implementation and broader adoption of CyPath® Lung. David Ost, MD, MPH, University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New York University Langone Medical Center, and J. Scott Ferguson, MD, University of Wisconsin School of Medicine and Public Health, were named to the Company’s panel of experts. The Company released three additional patient case studies in first quarter 2026 in which CyPath® Lung results of “Unlikely Malignancy” helped avoid unnecessary invasive and costly biopsies when other tests suggested the presence of lung cancer in patients at high risk. CyPath® Lung test results were confirmed by follow-up imaging that showed stable or resolved lung nodules. Management Commentary “Our first quarter results demonstrate continued momentum for CyPath® Lung in the marketplace. As more and more physicians adopt CyPath® Lung and share their experiences with peers, we see the opportunity to expand our commercial reach and bridge the diagnostic gap between imaging and invasive procedures, especially when dealing with indeterminate nodules in high-risk patients,” said Maria Zannes, President and CEO of bioAffinity Technologies. “We are accelerating our marketing strategy to expand access to CyPath® Lung and educate healthcare practitioners and patients alike about the need for accurate, objective information to better stratify risk and improve patient outcomes. On April 8, we hosted our first webinar featuring a panel of pulmonologists who shared how they use CyPath® Lung in their diverse practices.” Ms. Zannes continued, “Physicians continue to share their case studies in which CyPath® Lung has identified lung cancer as early as Stage 1A when it is most treatable and conversely in which a negative CyPath® Lung result helped avoid unnecessary invasive procedures. We believe the growing number of case studies and our longitudinal clinical trial, supported by leading military and VA institutions, will lead to broader adoption of CyPath® Lung as part of the standard of care.” Ms. Zannes concluded, “We are uniquely positioned to fulfill the need for an accurate, noninvasive diagnostic for lung cancer, particularly when imaging and risk models are inconclusive or turn out to be wrong. The remainder of 2026 will be focused on scaling commercial execution, expanding into new geographic markets, and driving increased utilization of CyPath® Lung through continued physician engagement while also leveraging our flow cytometry and AI platform to advance our pipeline of diagnostics for serious or life-threatening lung diseases.” First Quarter 2026 Financial Results Revenue for the quarter ended March 31, 2026, was $1.4 million. Revenue was primarily generated from patient service fees, histology services, and medical director fees. Operating expenses for the first quarter of 2026 were $5.0 million, compared with $4.5 million in the first quarter of 2025. Direct costs and expenses for the first quarter of 2026 were $0.9 million, down 32% from $1.4 million in the prior-year period, primarily due to targeted strategic actions implemented in March 2025. Research and development expenses decreased 5% year-over-year to $350,000, reflecting lower employee compensation and lab supply costs. Clinical development expenses rose to $334,000, driven by higher professional fees supporting the Company’s longitudinal clinical trial strategy. Selling, general and administrative expenses were $3.2 million for the first quarter of 2026, up from $2.5 million in the same period last year. The increase was primarily driven by higher employee compensation related to administrative and sales functions, reflecting the addition of personnel and support services to scale the commercialization of CyPath® Lung. Net loss for the quarter ended March 31, 2026, was $3.6 million, or $(0.81) per share, compared with a net loss of $2.7 million, or $(4.80) per share, for the first quarter of 2025. Cash and cash equivalents as of March 31, 2026, were $3.1 million, compared with $6.4 million as of December 31, 2025. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to obtain additional financing to fund operations, the Company's limited operating history and history of net losses, the Company's ability to achieve broader market acceptance of CyPath® Lung, the Company's dependence on key personnel, risks related to the regulatory environment for laboratory developed tests, the Company's ability to maintain and protect its intellectual property, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. bioAffinity Technologies, Inc.
Consolidated Balance Sheets March 31, 2026 December 31, 2025 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 3,098,366 $ 6,449,782 Accounts and other receivables, net 685,235 541,962 Inventory 77,887 53,548 Prepaid expenses and other current assets 479,913 519,916 Total current assets 4,341,401 7,565,208 Non-current assets: Property and equipment, net 246,849 265,593 Operating lease right-of-use asset, net 651,430 334,289 Finance lease right-of-use asset, net 586,048 661,575 Goodwill 1,404,486 1,404,486 Intangible assets, net 702,222 716,806 Other assets 12,816 12,815 Total assets $ 7,945,252 $ 10,960,772 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 836,211 $ 761,901 Accrued expenses 2,033,924 1,717,989 Unearned revenue 31,140 42,405 Operating lease liability, current portion 142,303 139,220 Finance lease liability, current portion 80,241 139,490 Notes payable, current portion 61,141 105,161 Total current liabilities 3,184,960 2,906,166 Non-current liabilities Operating lease liability, net of current portion 545,157 202,878 Finance lease liability, net of current portion 514,834 532,759 Notes payable, net of current portion 38,915 41,313 Total liabilities 4,283,866 3,683,116 Commitments and contingencies (See Note 11) Stockholders’ equity: Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; 700 shares issued or outstanding at March 31, 2026, and December 31, 2025, respectively 1 1 Common stock, par value $0.007 per share; 350,000,000 shares authorized; 4,498,675 shares issued and outstanding as of March 31, 2026, and December 31, 2025 31,464 31,461 Additional paid-in capital 75,814,595 75,800,258 Accumulated deficit (72,184,674 ) (68,554,064 ) Total stockholders’ equity 3,661,386 7,277,656 Total liabilities, and stockholders’ equity $ 7,945,252 $ 10,960,772 bioAffinity Technologies, Inc.
Unaudited Consolidated Statements of Operations Three Months Ended
March 31, 2026 2025 Net Revenue $ 1,351,527 $ 1,853,597 Operating expenses: Direct costs and expenses 928,636 1,367,860 Research and development 349,707 367,386 Clinical development 334,040 138,353 Selling, general and administrative 3,241,602 2,452,549 Depreciation and amortization 114,518 154,588 Total operating expenses 4,968,503 4,480,736 Loss from operations (3,616,976 ) (2,627,139 ) Other income (expense): Interest income 10,026 542 Interest expense (14,722 ) (15,485 ) Other income — 2 Other expense (8,938 ) (9,642 ) Total other expense (13,634 ) (24,583 ) Net loss before provision for income taxes (3,630,610 ) (2,651,722 ) Income tax expense — (8,695 ) Net loss $ (3,630,610 ) $ (2,660,417 ) Net loss per common share, basic and diluted $ (0.81 ) $ (4.80 ) Weighted average common shares outstanding, basic and diluted 4,494,752 541,841 View source version on businesswire.com: https://www.businesswire.com/news/home/20260508460240/en/ bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com Original: bioAffinity Technologies Reports First Quarter 2026 Results and Expanding Adoption and Clinical Usage of CyPath® Lung
US Market News
2月前
bioAffinity Technologies Launches New Study To Expand Use of CyPath® Lung Technology for Asthma and COPD Diagnosis and TreatmentApril 28, 2026 9:16 AM
Business Wire
Collaboration with nation’s largest military medical center focuses on bioAffinity Technologies’ pipeline of solutions to address debilitating respiratory diseases
Study to explore the potential for proprietary flow cytometry+AI diagnostic tests targeting the asthma and COPD treatment market estimated at $92 billion1
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today announced a pilot study with Brooke Army Medical Center (BAMC) to evaluate the Company’s proprietary tests under development to identify specific inflammatory biomarkers for asthma and chronic obstructive pulmonary disease (COPD). The study could lead to the development of diagnostic tests designed to help align patients with the most effective treatments and help monitor the drugs’ effectiveness over time.
The research collaboration with BAMC builds on bioAffinity Technologies’ research pipeline, leveraging its proprietary flow cytometry+AI technology to develop precision diagnostics and treatments for common airway diseases by assessing the extent and type of lung inflammation.
“We have made tremendous strides over the last decade in our understanding of the pathophysiology of asthma and COPD,” said John J. Oppenheimer, MD, a leading authority on the diagnosis and treatment of asthma and COPD and professor at the University of Medicine and Dentistry of New Jersey-Rutgers. Dr. Oppenheimer also sits on the bioAffinity Technologies Board of Directors. “Emerging tools – such as bioAffinity’s cytometry+AI platform – will likely accelerate this progress by enabling direct assessment of a patient’s inflammatory milieu within the lung. With this level of resolution, we can better stratify the risk of disease progression and more accurately match the right medicine to the right patient.”
The study will enroll approximately 40 participants in three cohorts: patients with asthma, patients with COPD and a healthy control group. The objective of the study is to use automated analysis of sputum samples collected from patients with asthma and COPD to identify and measure select immune cell populations and cytokines in sputum that can direct treatment and monitor the effectiveness of therapies.
Asthma is not a single disease. It includes multiple inflammatory subtypes. In military personnel, asthma is generally not the classic allergic form seen in civilian populations, making diagnosis and treatment more challenging. Service members are exposed to a wide range of environmental, occupational and deployment-related hazards that can fundamentally alter how asthma presents and progresses.
“Our flow cytometry platform provides a novel, noninvasive way to assess lung inflammation at the cellular level,” said Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer. “By identifying a broader panel of inflammatory biomarkers, we hope to help shift asthma and COPD management toward a precision medicine model, where treatment is guided by each patient’s unique inflammatory signature rather than a one-size-fits-all approach. Our technology also has the potential to help physicians monitor treatment response over time, improving patient outcomes.”
The goal of the BAMC study is to determine whether the Company’s lung inflammation tests, including flow cytometry and enzyme-linked immunosorbent assay (ELISA) analysis, can help physicians tailor more effective treatment strategies for asthma and COPD. In the military context, a safe, reliable noninvasive way to assess lung inflammation could positively impact readiness and deployment decisions as well as long-term respiratory health outcomes for service members and veterans.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the early stage of the Company's asthma and COPD study and the uncertainty of its results; the ability to develop and commercialize new diagnostic tests; the regulatory status of the Company's products, including the evolving regulatory framework for Laboratory Developed Tests and the potential for increased FDA oversight; the need to obtain regulatory clearances or approvals for future products, including any companion diagnostics; the Company's ability to enroll participants in clinical studies; the Company's reliance on third-party collaborators, including military medical institutions; the competitive landscape for respiratory diagnostics; the Company's ability to protect its intellectual property; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
1 Grand View Research, COPD And Asthma Therapeutics Market (2025 - 2030)
View source version on businesswire.com: https://www.businesswire.com/news/home/20260428990130/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
Original: bioAffinity Technologies Launches New Study To Expand Use of CyPath® Lung Technology for Asthma and COPD Diagnosis and Treatment
Paulness
3月前
NEWS -- New Case Study: bioAffinity Technologies’ CyPath® Lung Diagnostic Supports Physician’s Assessment, Prompts Follow-Up Imaging and Defers Unnecessary Biopsy
Standard-of-care imaging and risk models indicated cancer after lung screening revealed 30-millimeter pulmonary nodule
CyPath® Lung test affirmed physician’s assessment that the nodule could be inflammation, not cancer; nodule resolved upon follow-up scan
Noninvasive CyPath® Lung performed with 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in more difficult to diagnose small nodules in a clinical trial of patients at high risk for lung cancer
SAN ANTONIO, April 14, 2026--(BUSINESS WIRE) -- bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today released a new clinical case study illustrating how CyPath® Lung, the Company’s noninvasive sputum-based diagnostic test, helped determine next steps for a high-risk patient with a suspicious pulmonary nodule where imaging and risk models suggested a high likelihood of cancer, but the physician suspected possible inflammation.
The patient, a 70-year-old female with a 50 pack-year smoking history and smoking-related emphysema, presented with increased symptoms including cough, sputum production and shortness of breath. A low-dose CT scan identified a suspicious 30-millimeter (mm) lesion in the lower right lung with nearby enlarged lymph nodes, findings that can be associated with lung cancer. PET imaging suggested a high likelihood of malignancy. Lung cancer risk calculators estimated the probability of cancer as high on the Mayo and Herder models and intermediate on the Brock model.
"In this case, imaging findings and risk calculators suggested a very high probability of lung cancer, and we scheduled her for biopsy," said Daya Nadarajah, MD, the treating pulmonologist. "I routinely use CyPath® Lung in my practice and ordered the test for her. She received a negative result, ‘Unlikely Malignancy,’ which prompted another scan before we moved forward with the biopsy."
A follow-up CT scan showed that the concerning 30-mm nodule had completely resolved, confirming the physician’s acumen that the abnormality was due to a reversible inflammatory process rather than lung cancer.
"In patients with underlying lung disease, like emphysema, or other comorbidities like cardiovascular disease, biopsy can carry significant risks. Physicians must weigh the risks against the potential benefits," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "Adding CyPath® Lung to the diagnostic pathway for indeterminate nodules provides additional objective data that can be very valuable when assessing patients with complicating health conditions. In this patient’s case, CyPath® Lung supported additional imaging before biopsy which resulted in saving the patient from a risky, costly and unnecessary procedure."
This case highlights how CyPath® Lung can assist physicians with pulmonary nodule management by helping physicians confidently defer unnecessary – and often risky – invasive procedures. This case study is illustrative of a single patient experience and does not establish generalized clinical utility.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. CyPath® Lung is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to indicate the probability of lung cancer, CyPath® Lung providing confidence in a proposed course of action for high-risk patients, the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260414087028/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
Paulness
3月前
NEWS -- bioAffinity Technologies’ CyPath® Lung to Be Featured at Cleveland Clinic Annual “Advances in Early Lung Cancer Detection” Symposium April 16
Invitation-only conference focuses on the evolving landscape of lung cancer risk and early detection when the disease is most treatable
bioAffinity Technologies Chief Medical Officer Gordon Downie, MD, PhD, to participate in panel on lung nodule management
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, announces that its CyPath® Lung test will be featured at the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic in Cleveland, Ohio, on April 16, 2026. Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer, will be one of three panelists discussing lung nodule management and highlighting the benefits of using CyPath® Lung to aid in the early detection of lung cancer in high-risk patients.
The seventh annual Cleveland Clinic symposium brings together global leaders in the field of lung cancer, including physicians, advocacy organizations, researchers and industry, to accelerate the development and implementation of new technologies and methods to find lung cancer at the earliest stages when it is most treatable. This is bioAffinity Technologies’ seventh invitation to present before symposium attendees.
This year’s agenda addresses lung cancer risk assessment, emerging diagnostic technologies, screening biomarkers and artificial intelligence (AI) as well as the changing epidemiology of lung cancer.
“As the number of indeterminate pulmonary nodules discovered incidentally and by lung screening continues to grow, so does the accompanying need for noninvasive, scalable diagnostic solutions,” Dr. Downie said. “CyPath® Lung directly addresses many of the issues that will be discussed at the Cleveland Clinic’s symposium. Using our sputum-based diagnostic as an adjunct to the current standard of care for newly discovered non-calcified pulmonary nodules helps guide difficult clinical discussions, accelerates diagnosis and prevents unnecessary invasive procedures. Adding CyPath® Lung to the diagnostic pathway provides actionable results to physicians, eases anxiety for patients, and can reduce costs to the healthcare system.”
CyPath® Lung is a noninvasive, cost-effective diagnostic test that uses flow cytometry and AI to analyze the lung microenvironment and identify cancer and cancer-related cells. Clinical data and case studies have shown its potential to detect cancer as early as Stage 1A, while a negative result can help avert unnecessary and often risky invasive procedures.
With both high sensitivity and specificity, CyPath® Lung is a balanced test that supports clinical decision-making and is broadly applicable in high-risk patients, regardless of nodule size or prior cancer history. Initially designed to assist in the evaluation of indeterminate pulmonary nodules identified through screening or incidental imaging, CyPath® Lung can also be used to monitor lung cancer survivors for recurrence.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to aid in the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that may indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. Results may vary in broader clinical use.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the evolving regulatory landscape for Laboratory Developed Tests, including potential increased oversight by the U.S. Food and Drug Administration, the Company's ability to achieve and maintain market acceptance of CyPath® Lung, the Company's ability to obtain adequate financing to fund operations, risks related to the commercialization of CyPath® Lung, and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260407925579/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
Paulness
3月前
NEWS -- bioAffinity Technologies’ CyPath® Lung Test Unit Sales Surged 146% Year-Over-Year in Q1 2026
Noninvasive diagnostic continues to gain traction in the current and expanding U.S. addressable market of $3.58 billion for pulmonary nodule management and surveillance of lung cancer survivors
Flow cytometry+AI technology has potential to improve lung cancer risk assessment and nodule management
SAN ANTONIO, April 01, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced that unit sales for its CyPath® Lung diagnostic in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, achieved 146% growth compared to the first quarter of 2025, reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive lung cancer diagnostic test.
"The stronger than expected unit growth in the first quarter of 2026 reflects growing recognition of the value that CyPath® Lung brings to clinical decision-making and patient outcomes," said Maria Zannes, President and CEO of bioAffinity Technologies. "Physicians are seeking more accurate, noninvasive tools to assess lung cancer risk and detect disease at its earliest, most treatable stage. CyPath® Lung is designed to address a critical gap in the diagnostic pathway by supporting lung cancer risk assessment, pulmonary nodule management and post-treatment surveillance. Our growing body of evidence – including real-world case studies – further supports CyPath® Lung’s potential clinical utility."
Addressing a Large and Growing Clinical Need
The number of patients identified with indeterminate pulmonary nodules continues to rise, driven in part by increases in incidental findings and screening by low-dose CT for high-risk patients. This expanding patient population poses a diagnostic challenge for physicians who have to weigh the benefits and risks of "watchful waiting" versus invasive procedures like biopsy.
Consistent with estimates from the U.S. Preventive Services Task Force, the number of indeterminate pulmonary nodules detected in the U.S. through lung cancer screening and incidental imaging is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030. The number of people living with a prior lung cancer diagnosis is projected to increase from 680,000 to more than 871,000 by 2030. Capturing only 10% of both markets represents sales of $358 million for CyPath® Lung, growing to more than $560 million over the next five years. The forecast assumes 10% compound annual growth from 2024–2030, driven by increased lung cancer screening adoption, improved adherence to screening guidelines, and enhanced detection through AI-enabled imaging tools.
CyPath® Lung’s flow cytometry+AI technology is designed to provide actionable information to support clinical decision-making by delivering a binary result – "likely" or "unlikely" malignancy – to the ordering physician. Real-world patient cases have suggested the test’s potential to:
Help detect lung cancer at Stage 1A, when it is most treatable, as observed in real-world clinical cases.
Help avoid unnecessary invasive, risky, and costly procedures when the test result is negative ("unlikely" malignancy), based on clinical experience to date.Executing a Focused Commercial Strategy
bioAffinity Technologies has prioritized CyPath® Lung as its core commercial focus, aligning resources to accelerate adoption and scale. Growth has been driven by:
Expansion of ordering physician sites.
Increased peer-to-peer education among pulmonologists.
Integration of CyPath® Lung into clinical workflows for lung cancer risk assessment and nodule management.Based on audited financial results, CyPath® Lung revenue increased 87% year over year in 2025, while test units sold grew 99% compared to 2024. These milestones, together with preliminary unaudited growth data for Q1 2026, support the initial phase of the Company’s commercialization strategy and position CyPath® Lung for continued growth.
Positioned for Continued Expansion
The Company is advancing multiple initiatives to further expand the clinical impact of its proprietary technology platform, including:
A large-scale longitudinal clinical study designed to generate additional validation data for CyPath® Lung.
Broader use of CyPath® Lung to monitor lung cancer survivors after treatment.
An R&D pipeline that includes diagnostic tests for asthma and COPD that will help guide personalized treatment with targeted therapies.About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. Results may vary in broader clinical use.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to successfully commercialize and achieve market acceptance of CyPath® Lung, the Company's ability to achieve and sustain profitability, the preliminary and unaudited nature of certain financial and operating data presented herein, the Company's reliance on a single commercial product, the outcome of ongoing and future clinical studies, the Company's ability to obtain and maintain adequate reimbursement from third-party payors, the regulatory environment for laboratory developed tests, the Company's ability to attract and retain qualified personnel, the Company's need for additional capital to fund operations, competition from existing and new diagnostic technologies, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260401043688/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
Paulness
3月前
NEWS -- bioAffinity Technologies to Host Live Virtual Physician Roundtable on Integrating CyPath® Lung into Pulmonary Practice
Panel of leading pulmonologists will share real-world patient cases and benefits of clinical use of the noninvasive CyPath® Lung diagnostic test
First of "CyPath® Lung in Practice" webinar series focuses on need for greater certainty when diagnosing indeterminate pulmonary nodules
Healthcare providers can register here for the April 8, 2026, webinarSAN ANTONIO, March 25, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced it will host the first of a series of live virtual physician roundtables featuring pulmonologists who will discuss their use of CyPath® Lung in clinical practice as part of a comprehensive approach to lung cancer risk assessment, pulmonary nodule management and surveillance of lung cancer survivors post-treatment.
During the webinar, participating physicians will share real-world case studies in which CyPath® Lung helped guide clinical decision-making. Cases that demonstrate CyPath® Lung’s clinical utility range from identifying lung cancer at Stage 1A when it is curative to preventing unnecessary invasive, risky and costly procedures when CyPath® Lung resulted in "Unlikely" malignancy.
The interactive session will provide pulmonologists and other healthcare professionals with practical insights into adding CyPath® Lung to the diagnostic pathway for patients at high risk for lung cancer. Healthcare professionals interested in learning how CyPath® Lung can be incorporated into pulmonary practice are encouraged to register.
Webinar Details
Title: CyPath® Lung in Practice: A Physician Roundtable Discussion
Format: Live Zoom webinar. The webinar will be recorded and posted on the CyPath® Lung website.
Date/Time: Wednesday, April 8, 2026, at 7 p.m. ET/6 p.m. CT.
Registration: https://bit.ly/4ruhbJO
Moderator: Gordon H. Downie, MD, PhD
Pulmonologist and Chief Medical Officer of bioAffinity Technologies with more than 35 years of experience in pulmonary and critical care medicine and lung cancer diagnostics.
Panelists:
Sai Karan Vamsi Guda, DO
Interventional pulmonologist with Texas Pulmonary & Critical Care Consultants in Fort Worth specializing in robotic bronchoscopy, airway stenting, and minimally invasive diagnosis and treatment of lung disease.
Michael Nicholson, DO
Pulmonologist and critical care specialist with RWJBarnabas Health Medical Group in New Jersey with expertise in advanced lung disease and a clinical focus on enhancing noninvasive malignancy risk stratification in patients with pulmonary nodules.
Gregory White, MD
Pulmonologist at CHRISTUS Trinity Clinic specializing in comprehensive pulmonary care, including advanced bronchoscopy and treatment of lung cancer, asthma, and COPD, with a patient-focused, personalized approach.About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to aid in the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that may indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to successfully commercialize CyPath® Lung, the adoption of CyPath® Lung by physicians and healthcare providers, the Company’s ability to obtain and maintain regulatory approvals, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260325106814/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
US Market News
4月前
New Case Study: bioAffinity Technologies’ CyPath® Lung Provides Actionable Results and Helps Patient Avoid Costly, Invasive ProceduresMarch 17, 2026 7:45 AM
Business Wire
CyPath® Lung improves diagnostic clarity in patients with multiple lung nodules
In this case study, CyPath® Lung “Unlikely Malignancy” result supported physician’s decision to wait before ordering an invasive lung biopsy
In a clinical study, noninvasive CyPath® Lung test demonstrated 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules less than 20 millimeters
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today released a new clinical case study that highlights the benefit of adding CyPath® Lung, a noninvasive test for lung cancer, to the diagnostic pathway for a high-risk patient with multiple pulmonary nodules.
The patient is a 71-year-old former 20-pack-year smoker with a history of pneumonia in the right lower lobe. His current medical condition includes obesity and mild restrictive lung disease. Low dose CT scans revealed scattered pulmonary nodules, with one measuring 7 millimeters (mm), a size that has a greater potential for being cancerous and often leads to invasive bronchoscopy or biopsy.
“Multiple small nodules in a high-risk patient pose a diagnostic challenge, which can be exacerbated by the patient’s understandable anxiety about a potential cancer,” said Daya Nadarajah, MD, the patient’s pulmonologist. “In this case, the patient’s CyPath® Lung result was negative, indicating a low likelihood of malignancy, and together both the patient and I were comfortable in waiting for a follow-up CT scan in three months.”
The follow-up scan in October 2025 showed the suspicious nodules in the right upper lobe had resolved, indicating benign inflammation, and a small nodule located in the fissure between the upper and lower right lobes remained unchanged.
“This is another patient case study that illustrates how CyPath® Lung provides accurate results and greater confidence in pulmonary nodule management, supporting physician decision-making, reducing patient anxiety, and lowering healthcare costs by avoiding expensive, invasive and often risky procedures when they are not necessary,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to aid in the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that may indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical study, CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to indicate the probability of lung cancer, CyPath® Lung providing confidence in a proposed course of action for high-risk patients, the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free, the ability of CyPath® Lung to lower healthcare costs, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260317808939/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
Original: New Case Study: bioAffinity Technologies’ CyPath® Lung Provides Actionable Results and Helps Patient Avoid Costly, Invasive Procedures
US Market News
4月前
bioAffinity Technologies Announces Record 2025 Revenue and Unit Sales for Flagship Lung Cancer Diagnostic CyPath® LungMarch 13, 2026 8:00 AM
Business Wire
Laboratory business streamlined in 2025 to focus on profitable diagnostic testing services including the Company’s high-value CyPath® Lung test
Number of CyPath® Lung tests performed in 2025 increased by 99% compared to 2024
Orders for CyPath® Lung by physicians and clinics rose 67% YoY due to peer-to-peer marketing, positive real-world experiences and growing test awareness
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the year ended December 31, 2025.
2025 Highlights
Record CyPath® Lung Revenue and Unit Sales. Revenue from our noninvasive diagnostic for lung cancer increased 87% over 2024 with the number of tests performed rising 99% year over year, reflecting growing clinical utilization and validating the first phase of our commercialization strategy. The Company’s strategic decision to discontinue unprofitable pathology services and reallocate resources to the commercialization of CyPath® Lung led to a 34% decrease in total revenue and a 9% decrease in operating expenses compared to 2024, respectively.
Expanded Physician Network. The number of physician offices and clinics ordering CyPath® Lung for their patients increased 67% over 2024. We expect the trend to accelerate in 2026 as we expand our sales force into new markets. Peer-to-peer physician engagement remains a key driver of growth. Compelling patient case studies and key opinion leaders (KOLs) who are sharing their clinical experience are building awareness and clinical adoption of CyPath® Lung.
Leadership Appointments. Gordon Downie, MD, PhD, joined bioAffinity Technologies as Chief Medical Officer, bringing more than three decades of experience in pulmonary medicine, clinical research, medical innovation, and interventional pulmonology to the role. Roberto Rios, CPA, and John J. Oppenheimer, MD, were appointed to the Board of Directors in 2025. Mr. Rios has more than four decades of executive leadership experience in corporate finance and governance across industries including biotechnology and medical devices. Dr. Oppenheimer is a recognized leader in the diagnosis and treatment of asthma and COPD and directs clinical research in lung health while also teaching at the University of Medicine and Dentistry of New Jersey-Rutgers.
Successful Financings. The Company raised approximately $16.9 million in gross proceeds during 2025 from equity transactions to fund CyPath® Lung clinical development, commercialization, and operational expansion.
CyPath® Lung-Centered Performance. Through targeted operational streamlining and the discontinuation of certain unprofitable pathology services at our laboratory, Precision Pathology Laboratory Services (PPLS), we positioned CyPath® Lung as the core driver of long-term shareholder value. While these actions contributed to lower consolidated revenue in the short term, they improved operating focus and cost structure and are intended to position our noninvasive lung cancer diagnostic for scalable growth and improved long-term margin potential.
Innovation Pipeline Progress. Research and development continued on diagnostic tests for chronic obstructive pulmonary disease (COPD) and asthma that build on our expertise in using sputum as a sample for flow cytometric analysis. Research is focused on detecting specific receptors in sputum to guide personalized treatment and identify patients likely to benefit from emerging targeted therapies. Asthma and COPD impact approximately 650 million children and adults globally.1 We expect to begin patient studies in 2026.
Expanded Global Intellectual Property Portfolio. During 2025, we strengthened our intellectual property portfolio supporting CyPath® Lung and our broader flow cytometry platform through multiple patent allowances and acceptances. These included notification of allowance from the U.S. Patent and Trademark Office for our diagnostic algorithm and test method, patent allowances in Canada and China covering flow cytometry-based lung cancer detection methods, and acceptance of patent applications in Australia related to early-stage lung cancer detection and multi-disease lung health assessment. These developments further expand international protection of our diagnostic technology and support our long-term commercialization strategy.
Management Commentary
“2025 was a transformational year for bioAffinity Technologies. We took deliberate actions to streamline operations at PPLS and align our resources behind the national expansion of CyPath® Lung,” said Maria Zannes, bioAffinity President and Chief Executive Officer. “While these actions contributed to a decrease in consolidated revenue, we believe that the Company is now better positioned to leverage revenue generated from the profitable testing services performed in our lab. Importantly, revenue for our core value driver, CyPath® Lung, increased 87% year over year, reflecting continued physician adoption and growing clinical utilization.
“The work we accomplished in 2025 was intentional and strategic. We strengthened our capital base, removed unprofitable legacy services from PPLS services and concentrated on high-value diagnostics. The launch of our longitudinal trial and our ongoing integration into the military healthcare system are both significant milestones that support our strategy of establishing CyPath® Lung as a standard of care for indeterminate pulmonary nodules and a tool for surveillance after cancer treatment.
“Every day, we hear from practitioners who confirm the need for noninvasive, accurate lung cancer diagnostics, particularly when imaging and risk models are inconclusive or turn out to be wrong. CyPath® Lung remains our first priority. It is a gamechanger that provides clinical confidence for physicians and better outcomes for patients. We believe our focus on improving care for patients at risk for lung cancer and other pulmonary diseases will create long-term value for our shareholders.”
2026 Outlook
Financial Outlook. bioAffinity entered 2026 with strong momentum, building on a year of increased sales and revenue growth and positioning the Company for continued expansion in the lung cancer diagnostics market. Our forecast for unit sales of CyPath® Lung reflects an increase of greater than 100% over 2025, with a corresponding increase in revenues for our noninvasive lung cancer diagnostic. We will continue to expand our market both geographically and by the number of physicians and medical facilities adding CyPath® Lung to the diagnostic pathway for patients with indeterminate pulmonary nodules and to post-treatment care for surveillance of lung cancer survivors.
Market Opportunity. Consistent with estimates from the US Preventive Services Task Force, the number of indeterminate pulmonary nodules detected in the U.S. through lung cancer screening and incidental imaging is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030, representing an estimated market opportunity exceeding $4.7 billion for CyPath® Lung. The forecast assumes 10% compound annual growth from 2024–2030, driven by increased lung cancer screening adoption, improved adherence to screening guidelines, and enhanced detection through AI-enabled imaging tools. Another market opportunity opening up for CyPath® Lung is its potential to improve post-treatment surveillance for lung cancer survivors. The number of Americans living with lung cancer is projected to increase 28% from 680,450 in 2025 to 871,580 in 20352, representing an estimated $870 million market opportunity over the next decade.
CyPath® Lung Longitudinal Trial. In March 2026, we enrolled the first patient in our longitudinal study evaluating CyPath® Lung as a noninvasive diagnostic for high-risk patients with indeterminate pulmonary nodules. The trial plans to enroll up to 2,000 patients across 17 Veterans Administration (VA), military, academic, and private medical centers and will assess the sensitivity and specificity of the test over a follow-up period of up to two years. The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities. This study is intended to provide additional clinical validation to support broader adoption in federal and commercial markets.
Military Research Collaboration to Expand Sample Collection Options for CyPath® Lung. In February 2026, we announced a collaboration with Brooke Army Medical Center (BAMC) to evaluate the use of CyPath® Lung on sputum samples obtained via tracheal and bronchial suctioning during bronchoscopy. This study is designed to assess the clinical utility of CyPath® Lung for earlier detection of lung cancer in patients undergoing standard bronchoscopy procedures, potentially expanding the test’s applicability to a larger patient population and increasing integration into pulmonology workflows.
Real-World Case Studies Validate CyPath® Lung. The Company released 10 patient case studies in 2025 including multiple cases in which CyPath® Lung detected curative Stage 1A lung cancer. In February 2026, we released two new real-world clinical cases in which a negative CyPath® Lung test result supported the physician’s decision to continue monitoring high-risk patients with indeterminate nodules through noninvasive surveillance. CyPath® Lung guided physician decision-making and reduced the burden on the patients by easing anxiety and helping them avoid additional invasive, costly and often risky procedures. The body of clinical evidence behind CyPath® Lung and real-world case studies continues to grow.
Positive Findings Presented at AAAAI on Expansion of Platform Technology to Asthma. In February 2026, the Company presented research on the ability of our innovative diagnostic platform to identify antibody drug receptors in sputum, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy. The research supports advancement of the Company’s pipeline tests aimed at guiding personalized treatment decisions and improving disease monitoring for asthma and COPD sufferers.
2025 Financial Results
Revenue was $6.2 million, compared with $9.4 million for 2024. The decrease reflects targeted strategic actions to discontinue certain unprofitable services and reallocate resources toward CyPath® Lung. Testing revenue for CyPath® Lung increased 87% year-over-year, driven by increased adoption by physicians and clinics, including the VA.
Operating expenses decreased 9% to $16.7 million in 2025, primarily due to strategic actions aimed at streamlining and reducing lab operation costs.
Research and development expenses were $1.4 million in 2025, slightly lower than the prior year, reflecting ongoing investment in lab operations and preclinical development.
Selling, general and administrative expenses remained flat at $9.9 million.
Net loss for the year ended December 31, 2025, was $14.9 million, compared to $9.0 million for 2024. The increase was primarily attributable to changes in the fair value of warrants, expanded sales activities and increased clinical development.
Cash and cash equivalents as of December 31, 2025, were $6.5 million, compared with $1.1 million at the end of 2024. The Company raised $16.9 million in multiple financings in 2025 to support ongoing operations.
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1
https://academic.oup.com/ajrccm/article/212/2/297/8444672?login=false&utm
2
*Wagel, et al. Cancer treatment and survivorship statistics, 2025 CA Cancer J Clin. 2025 Sep 13;75(6):683.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to successfully commercialize and achieve market acceptance of CyPath® Lung; the Company’s ability to raise additional capital to fund operations; the Company’s history of losses and ability to achieve profitability; the Company’s reliance on CyPath® Lung as its primary revenue-generating product; changes in the regulatory landscape for laboratory developed tests, including potential FDA oversight; the Company’s ability to obtain and maintain adequate reimbursement from third-party payors; the outcome of the Company’s clinical trials and studies; the Company’s ability to attract and retain qualified personnel; competition from existing and new diagnostic techniques; the Company’s ability to protect its intellectual property; the Company’s ability to maintain its Nasdaq listing; general economic, political, and market conditions; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 to be filed with the Securities and Exchange Commission today, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
bioAffinity Technologies, Inc.
Consolidated Balance Sheets
As of December 31, 2025 and 2024
December 31,
2025
2024
ASSETS
Current assets:
Cash and cash equivalents
$
6,449,782
$
1,105,291
Accounts and other receivables, net
541,962
1,139,204
Inventory
53,548
27,608
Prepaid expenses and other current assets
519,916
422,995
Total current assets
7,565,208
2,695,098
Non-current assets:
Property and equipment, net
265,593
375,385
Operating lease right-of-use asset, net
334,289
463,011
Finance lease right-of-use asset, net
661,575
780,872
Goodwill
1,404,486
1,404,486
Intangible assets, net
716,806
775,139
Other assets
12,815
19,676
Total assets
$
10,960,772
$
6,513,667
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
761,901
$
987,311
Accrued expenses
1,717,989
1,398,722
Unearned revenue
42,405
24,404
Operating lease liability, current portion
139,220
127,498
Finance lease liability, current portion
139,490
395,301
Notes payable, current portion
105,161
171,669
Total current liabilities
2,906,166
3,104,905
Non-current liabilities
Operating lease liability, net of current portion
202,878
342,098
Finance lease liability, net of current portion
532,759
444,448
Notes payable, net of current portion
41,313
20,180
Total liabilities
3,683,116
3,911,631
Stockholders’ equity:
Preferred stock, $0.001 per share; 20,000,000 shares authorized; 700 and 0 shares issued and outstanding at December 31, 2025 and 2024, respectively
1
—
Common Stock, par value $0.007 per share; 350,000,000 shares authorized; 4,498,675 and 519,158 issued and outstanding at December 31, 2025 and 2024, respectively(1)
31,461
106,593
Additional paid-in capital(1)
75,800,258
56,139,753
Accumulated deficit
(68,554,064
)
(53,644,310
)
Total stockholders’ equity
7,277,656
2,602,036
Total liabilities and stockholders’ equity
$
10,960,772
$
6,513,667
(1)
The values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted in order to give effect to the Company’s 1-for-30 reverse stock split.
bioAffinity Technologies, Inc.
Consolidated Statements of Operations
For the Years Ended December 31, 2025 and 2024
2025
2024
Net Revenue
$
6,161,959
$
9,362,022
Operating expenses:
Direct costs and expenses
4,226,799
5,983,475
Research and development
1,383,359
1,461,227
Clinical development
705,744
321,655
Selling, general and administrative
9,913,729
9,943,473
Depreciation and amortization
504,836
605,637
Total operating expenses
16,734,467
18,315,467
Loss from operations
(10,572,508
)
(8,953,445
)
Other income (expense):
Interest income
23,385
17,610
Interest expense
(44,372
)
(92,475
)
Other income
40,490
10,323
Other expense
(502,429
)
(10,194
)
Change in fair value of warrants issued
(3,810,278
)
—
Loss before income tax expense
(14,865,712
)
(9,028,181
)
Income tax expense
(44,042
)
(11,650
)
Net loss
$
(14,909,754
)
$
(9,039,831
)
Net loss per common share, basic and diluted(2)
$
(8.66
)
$
(22.50
)
Weighted average common shares outstanding(2)
1,721,082
404,167
(2)
The values of Common Stock and paid-in capital, as well as the number of shares issued and outstanding, have been retroactively adjusted in order to give effect to the Company’s 1-for-30 reverse stock split.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260313834345/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
Original: bioAffinity Technologies Announces Record 2025 Revenue and Unit Sales for Flagship Lung Cancer Diagnostic CyPath® Lung
US Market News
4月前
bioAffinity Technologies Announces Initiation of Large-Scale Longitudinal Clinical Study for Its Noninvasive CyPath® Lung Cancer DiagnosticMarch 10, 2026 7:47 AM
Business Wire
Study to evaluate clinical performance of CyPath® Lung for the early detection of lung cancer in high-risk patients
Murtha Cancer Center Research Program at Uniformed Services University of the Health Sciences provides support for longitudinal study
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on non-invasive diagnostics and early cancer detection, today announced initiation of the Company’s planned large-scale, longitudinal clinical study for CyPath® Lung, its noninvasive diagnostic test for the detection of early-stage lung cancer.
The 2,000-patient longitudinal study is designed to evaluate the clinical performance of the CyPath® Lung flow cytometry test as a noninvasive diagnostic that uses sputum samples to detect the presence of lung cancer in high-risk individuals with existing lung nodules six millimeters (mm) to less than 30 mm in diameter identified by lung cancer screening. In an earlier clinical trial, CyPath® Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients with small pulmonary nodules less than 20mm. Several recent patient case studies demonstrate the test’s ability to detect lung cancer at its curative Stage 1A.
bioAffinity Technologies expects up to 20 clinical study sites, including a dozen Department of Veterans Affairs (VA) medical centers and two of the nation’s largest military hospitals, will participate in the study. Michael J. Morris, MD, pulmonology and critical care physician at Brooke Army Medical Center, is the national Principal Investigator for the study (NCT07168993). The John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, is providing support and funding associated with the trial at several federal facilities.
Physicians currently order CyPath® Lung, a laboratory developed test (LDT) offered by bioAffinity Technologies’ subsidiary Precision Pathology Laboratory Services, for their patients with indeterminate lung nodules to determine next steps in patient care.
The longitudinal clinical trial announced today will evaluate FlowPath Lung, a research-use test that uses the same technology and follows the same procedures as CyPath® Lung. The different name is simply used to distinguish the investigational assay from the commercially available test.
“As more indeterminate pulmonary nodules are found either incidentally or by routine lung cancer screening, CyPath® Lung can fill the diagnostic gap between ‘watchful waiting’ and invasive procedures that carry risk,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. “As a result, we see growing adoption and use of CyPath® Lung by physicians and expect this longitudinal trial to provide additional evidence to support inclusion of our noninvasive test as part of the standard of care for lung cancer screening and diagnosis.”
“Initiating this study represents an important milestone for CyPath® Lung,” said Maria Zannes, President and CEO of bioAffinity Technologies. “By following patients longitudinally across multiple sites, we expect to acquire robust, real-world data that reflects how CyPath® Lung may be used to support risk assessment and clinical decision-making aligned with our objective to establish CyPath® Lung as a standard of care for evaluating patients at high-risk for early-stage lung cancer.”
The study includes participation from several federal facilities to examine the test's performance in diverse patient populations, including military service members and veterans. Patient enrollment is expected to take up to 18 months with patients followed for up to 24 months or until a definitive diagnosis of cancer or no cancer is determined.
About CyPath® Lung
CyPath® Lung is a non-invasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for non-invasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a non-invasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to identify lung cancer in difficult-to-diagnose patients; the benefits of adding CyPath® Lung to the standard of care for evaluating indeterminate lung nodules; CyPath® Lung providing clarity when imaging and risk models are inconclusive; the ability to initiate and conduct the study as planned; challenges in patient identification, enrollment, retention, and protocol adherence; site performance and operational execution; variability in study data and outcomes; the possibility that study results do not demonstrate the anticipated performance or clinical utility; changes in standards of care, competitive developments, or technological advances; delays or difficulties in obtaining, maintaining, or expanding regulatory approvals or clearances; manufacturing, quality, supply chain, and scaling challenges; reimbursement and coverage uncertainties; the ability to obtain clinician and patient adoption; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260310050054/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
Original: bioAffinity Technologies Announces Initiation of Large-Scale Longitudinal Clinical Study for Its Noninvasive CyPath® Lung Cancer Diagnostic
Paulness
4月前
NEWS -- bioAffinity Technologies Presents Positive Research Findings for its Novel Diagnostic Platform Technology to Identify Optimal Therapies for Asthma Patients
Poster presented to medical and drug industry conferees at prestigious American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting
Research demonstrates the technology’s ability to identify drug antibody receptors in sputum for two leading asthma therapiesSAN ANTONIO, March 03, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced the presentation of a new scientific poster reporting on the ability of the Company’s innovative diagnostic approach to identify antibody drug receptors in sputum, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy. The research advances the Company’s pipeline tests aimed at guiding personalized treatment decisions and improving disease monitoring for asthma and COPD sufferers.
The poster, "Sputum as a Diagnostic Tool for the Treatment of Asthma," was presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting in Philadelphia on March 1 by William Bauta, PhD, Chief Science Officer of bioAffinity Technologies. The research reports on the Company’s development of clinical diagnostics that may assist physicians in matching asthma and COPD patients with the most effective therapies and monitoring inflammatory changes over time to improve outcomes and lower the cost of healthcare.
"Asthma and COPD impact approximately 650 million children and adults globally. The good news is that there are very effective treatments for asthma and COPD that work well for some sufferers. However, many patients must try a series of different types of treatments before finding an effective therapy," Dr. Bauta said. "We are leveraging our expertise in using our proprietary flow cytometry platform equipped with automated AI analysis to develop tests that match asthma and COPD patients with the most appropriate biologic therapies and monitor their ongoing conditions."
bioAffinity’s technology platform is successfully used with its commercial test, CyPath® Lung, a noninvasive diagnostic test for lung cancer that has demonstrated high sensitivity and specificity for patients with small pulmonary nodules in detecting lung cancer as early as curative Stage 1A.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, risks and uncertainties related to scientific research and development; the Company’s ability to develop, validate, obtain regulatory or other required clearances or approvals for, commercialize and achieve market acceptance of its diagnostic tests and related technologies; variability in clinical and real-world performance; the availability of sufficient data and sample sizes; changes in standards of care, competitive products and technologies; intellectual property protection; reliance on third parties; manufacturing and supply matters; reimbursement and coverage; and general economic, market and industry conditions; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260303182034/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
US Market News
4月前
bioAffinity Technologies Presents Positive Research Findings for its Novel Diagnostic Platform Technology to Identify Optimal Therapies for Asthma PatientsMarch 3, 2026 8:30 AM
Business Wire
Poster presented to medical and drug industry conferees at prestigious American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting
Research demonstrates the technology’s ability to identify drug antibody receptors in sputum for two leading asthma therapies
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced the presentation of a new scientific poster reporting on the ability of the Company’s innovative diagnostic approach to identify antibody drug receptors in sputum, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy. The research advances the Company’s pipeline tests aimed at guiding personalized treatment decisions and improving disease monitoring for asthma and COPD sufferers.
The poster, “Sputum as a Diagnostic Tool for the Treatment of Asthma,” was presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting in Philadelphia on March 1 by William Bauta, PhD, Chief Science Officer of bioAffinity Technologies. The research reports on the Company’s development of clinical diagnostics that may assist physicians in matching asthma and COPD patients with the most effective therapies and monitoring inflammatory changes over time to improve outcomes and lower the cost of healthcare.
"Asthma and COPD impact approximately 650 million children and adults globally. The good news is that there are very effective treatments for asthma and COPD that work well for some sufferers. However, many patients must try a series of different types of treatments before finding an effective therapy,” Dr. Bauta said. “We are leveraging our expertise in using our proprietary flow cytometry platform equipped with automated AI analysis to develop tests that match asthma and COPD patients with the most appropriate biologic therapies and monitor their ongoing conditions.”
bioAffinity’s technology platform is successfully used with its commercial test, CyPath® Lung, a noninvasive diagnostic test for lung cancer that has demonstrated high sensitivity and specificity for patients with small pulmonary nodules in detecting lung cancer as early as curative Stage 1A.
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, risks and uncertainties related to scientific research and development; the Company’s ability to develop, validate, obtain regulatory or other required clearances or approvals for, commercialize and achieve market acceptance of its diagnostic tests and related technologies; variability in clinical and real-world performance; the availability of sufficient data and sample sizes; changes in standards of care, competitive products and technologies; intellectual property protection; reliance on third parties; manufacturing and supply matters; reimbursement and coverage; and general economic, market and industry conditions; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260303182034/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
Original: bioAffinity Technologies Presents Positive Research Findings for its Novel Diagnostic Platform Technology to Identify Optimal Therapies for Asthma Patients
Paulness
4月前
NEWS -- bioAffinity Technologies Announces Validation Study with Brooke Army Medical Center to Expand Sample Collection Options for the CyPath® Lung Noninvasive Early Detection Lung Cancer Test
Validating sample collection by deep suction has potential to accelerate and expand adoption of CyPath® Lung
SAN ANTONIO, February 25, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced a new study with Brooke Army Medical Center (BAMC) to validate the clinical utility of using the CyPath® Lung diagnostic test to assess sputum samples obtained by tracheal and bronchial suctioning for early detection of lung cancer.
The study is designed to enroll approximately 30-50 patients undergoing routine tracheal or bronchial suctioning, with results from the study expected by mid-year 2026. Validating the performance of CyPath® Lung analysis on deep suction samples has the potential to expand the versatility of CyPath® Lung and support broader use in the detection of early-stage lung cancer.
"CyPath® Lung is a novel, noninvasive adjuvant diagnostic for patients at high risk for lung cancer," said Michael J. Morris, MD, pulmonology and critical care physician at BAMC. "The ability to use CyPath® Lung to analyze suctioned sputum collected during bronchoscopy and other procedures would leverage samples that we are already obtaining and expand access to earlier, more informed decision-making for patients at risk."
"Clinicians who have patients scheduled to undergo diagnostic bronchoscopy have told us that CyPath® Lung could be very helpful by providing an independent and complementary test for diagnosis," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "Physicians tell us they need additional tools for diagnosing indeterminate lung nodules, and this study demonstrates that we are listening to the clinicians using CyPath® Lung and responding to their needs."
Under the standard protocol for the CyPath® Lung test, patients with suspicious pulmonary nodules collect a sputum sample at home and send the sample overnight to the lab for processing. The deep suction study is designed to expand the options for sample collection by validating the use of CyPath® Lung with suctioned sputum samples, conducted in the clinic while patients undergo bronchial and tracheal suction procedures. Bronchial and tracheal suction may be used to clear airways and improve oxygenation. When used in conjunction with bronchoscopy, a suction catheter gently aspirates secretions from areas of concern within the lungs which can provide robust samples to obtain diagnostic information.
Bronchoscopy is used commonly in the United States, with approximately 500,000 procedures performed annually. The U.S. bronchoscopy procedure market, including devices and related technologies, is valued at $700–$920 million and continues to grow, driven by the rising prevalence of lung disease, including cancer and COPD, and adoption of innovative diagnostic tools. The CyPath® Lung study with BAMC will explore an approach that could expand the utility of bronchoscopy-collected samples for earlier, noninvasive lung cancer detection.
"BAMC is a leader in medical research with access to a large patient population representing the full range of pulmonary health," said Maria Zannes, President and CEO of bioAffinity Technologies. "We look forward to collaborating with BAMC and the potential to expand the reach of the AI-driven technology behind CyPath® Lung to detect lung cancer at the earliest, most treatable stage."
About Brooke Army Medical Center (BAMC)
Brooke Army Medical Center (BAMC), located at Joint Base San Antonio-Fort Sam Houston, Texas, is the United States Army’s premier academic medical center and the Department of War’s largest hospital. BAMC provides comprehensive inpatient and outpatient care to active-duty service members, veterans, their families, and civilian patients, supported by more than 8,000 military and civilian personnel. The center also serves as a teaching hospital and research institution with advanced specialty services, graduate medical education, and rehabilitation programs.
About CyPath® Lung
CyPath® Lung is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the timing, design, enrollment, conduct and anticipated results of the Brooke Army Medical Center study; the clinical utility, performance, versatility, or broader adoption or use of CyPath® Lung, including use with deep suction samples; the potential benefits, applications, market opportunity, or impact of CyPath® Lung or related technologies; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260225252955/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://jao@bioaffinitytech.com
US Market News
4月前
New Case Study Highlights Ability of bioAffinity Technologies’ CyPath® Lung to Reduce Diagnostic Burden for Patients At Risk for Lung CancerFebruary 19, 2026 11:00 AM
Business Wire
CyPath® Lung test supported recommendation for surveillance strategy, rather than subjecting elderly patient to an invasive, risky and costly biopsy procedure
Despite a suspicious nodule during a low-dose CT scan, a repeat scan showed no nodules in the lungs, validating the decision made with CyPath® Lung’s results
Noninvasive CyPath® Lung test has shown 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules less than 2 centimeters
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today released a new clinical case study in which its CyPath® Lung noninvasive diagnostic test for lung cancer helped determine the appropriate treatment for a 79-year-old female with a suspicious lung finding on a low-dose computed tomography (LDCT) scan.
The patient, a current smoker with a medical history significant for chronic obstructive pulmonary disease (COPD) and coronary heart disease, underwent LDCT screening in June 2025. Imaging revealed a spiculated, or irregularly shaped, nodule about half an inch in size at the bottom of the right lung, near the lining of the lung. Spiculated nodules raise concerns about malignancy due to their uneven, irregular appearance.
“Spiculated findings on CT scans often trigger concern and can lead to invasive procedures, particularly in older high-risk patients,” said Daya Nadarajah, MD, the patient’s pulmonologist. “Given this patient’s age, smoking history and comorbidities, we were not comfortable proceeding directly to an invasive procedure. CyPath® Lung gives us objective data to better stratify risk and avoid putting our patients through unnecessary and potentially risky procedures.”
The CyPath® Lung test result was negative, indicating an unlikely malignancy in the lung and supporting a conservative management approach that includes annual CT screening. A repeat scan in October 2025 showed that the suspicious finding from the June scan had resolved, and there were no pulmonary nodules in the lungs.
“Every suspicious finding is concerning. Even when the probability of malignancy is low, the consequences of missing a cancer are significant,” said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. “Physicians now have a tool in CyPath® Lung that further refines risk and provides valuable reassurance when deciding whether to monitor or escalate care.”
Supporting Confident, Noninvasive Management
Based on the reassuring imaging and negative CyPath® Lung result, the patient and her care team agreed to continue with serial annual CT scans as follow-up care. In this case, CyPath® Lung:
Provided the confidence to defer invasive procedures
Prevented an unnecessary biopsy
Put the patient at ease with ongoing surveillance
Complemented imaging findings in a high-risk individual
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to indicate a high probability of lung cancer, CyPath® Lung providing confidence in a proposed course of action for high-risk patients with spiculated nodules, the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260219406966/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com
Original: New Case Study Highlights Ability of bioAffinity Technologies’ CyPath® Lung to Reduce Diagnostic Burden for Patients At Risk for Lung Cancer
Paulness
5月前
NEWS -- Clinical Utility of bioAffinity Technologies’ CyPath® Lung Test Demonstrated in Real-World Case Study
Noninvasive CyPath® Lung test has shown 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules less than 2 centimeters
Case study highlights how CyPath® Lung reduces patient anxiety and supports physician confidence in assessment of benign pulmonary nodules
SAN ANTONIO, Texas, February 17, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today announced a new clinical case study demonstrating how CyPath® Lung, its noninvasive diagnostic test for lung cancer, supported clinical decision-making in a high-risk patient with multiple pulmonary nodules.
The 59-year-old patient had a 30-year, three packs per day smoking history and underlying chronic obstructive pulmonary disease (COPD). Imaging revealed multiple scattered pulmonary nodules measuring between 3–7 mm and categorized as Lung-RADS 3 on the Lung Imaging Reporting and Data System (Lung-RADS), indicating a probably benign condition.
"Determining appropriate care for a patient with multiple nodules and a significant smoking history is often complicated by patient anxiety and concern about an ongoing risk of malignancy," said Daya Nadarajah, MD, the patient’s pulmonologist. "Follow-up can be problematic without the additional diagnostic information provided by CyPath® Lung. A negative CyPath® Lung result helps reassure both physician and patient that an early cancer is unlikely to have been missed."
Dr. Nadarajah ordered a CyPath® Lung test for his patient, which returned a negative result of "unlikely malignancy." The CyPath® Lung score gave both physician and patient additional confidence to continue a serial six-month CT surveillance schedule, consistent with Lung-RADS 3 recommendations. In a follow-up CT scan, the sub-centimeter nodules remained stable.
"Patients with multiple small nodules and many years of tobacco use often face months of uncertainty and fear," said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. "CyPath® Lung provides physicians with additional, objective information that helps stratify risk and supports confident clinical decision-making while maintaining appropriate vigilance for patients at high risk for lung cancer."
Supporting Confident, Noninvasive Management
This case illustrates the benefit of using CyPath® Lung as an adjunctive diagnostic tool for managing indeterminate pulmonary nodules – particularly in high-risk smokers – by:
Supporting evidence-based surveillance decisions
Reinforcing guideline-consistent follow-up intervals
Potentially reducing invasive procedures on benign nodules
Helping alleviate patient anxietyAbout CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to indicate a high probability of lung cancer, CyPath® Lung providing confidence in a proposed course of action for high-risk patients when multiple pulmonary nodules are present, the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260217273895/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
Paulness
5月前
NEWS -- bioAffinity Technologies Appoints Nationally Recognized Pulmonary and Lung Cancer Authorities to its Medical and Scientific Advisory Board
Advisory Board provides independent guidance on strategic priorities, including growing adoption of the Company’s noninvasive CyPath® Lung diagnostic test
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced new appointments to its Medical and Scientific Advisory Board, welcoming David Ost, MD, MPH, University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New York University Langone Medical Center, and J. Scott Ferguson, MD, University of Wisconsin School of Medicine and Public Health, to its panel of recognized leaders in the field.
The appointments reflect a planned expansion of the Company’s Medical and Scientific Advisory Board to ensure alignment with bioAffinity’s current clinical, scientific, and commercial priorities, including the ongoing integration of CyPath® Lung, a noninvasive diagnostic test for lung cancer, into the standard of care for indeterminate pulmonary nodules.
Drs. Ost, Sterman and Ferguson join current board members David Hill, MD, Chair of the American Lung Association Board of Directors, Neil Alexis, PhD, Principal Investigator at the University of North Carolina School of Medicine Center for Environmental Medicine, Asthma and Lung Biology, Sheila Habib, MD, Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at South Texas Veterans Health Care Systems, Audie L. Murphy Memorial Veterans Hospital, and Sandeep Bansal, MD, Medical Director of Lung Innovations Network.
“Our Medical and Scientific Advisory Board’s extensive experience in real-world pulmonary practice and lung health supports our corporate and clinical mission to improve outcomes for patients by detecting lung cancer at the earliest stages when it is most treatable and survivable,” said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. “Lung cancer is still the leading cause of cancer-related deaths, and our focus remains on patient care, and how our CyPath® Lung diagnostic test can best inform clinicians and change the course of lung cancer diagnosis and treatment.”
Dr. Ost, a recognized leader in interventional pulmonology, thoracic oncology and critical care, currently serves as Professor of Medicine and Chief of Pulmonary, Critical Care, and Sleep Medicine at MD Anderson Cancer Center. His work focuses on improving lung cancer diagnosis, staging and treatment.
Dr. Sterman, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care, and Sleep Medicine at NYU Langone Health, is recognized for his pioneering work in interventional pulmonology. His research is focused on using gene therapy and immunotherapy to treat lung cancer and mesothelioma and improve and prolong the quality of patients’ lives.
Dr. Ferguson, Professor of Medicine and Director of Interventional Pulmonology at the University of Wisconsin School of Medicine and Public Health, specializes in treating complex lung conditions. He is recognized for his advanced diagnostic techniques for lung cancer, thoracic oncology and therapeutic bronchoscopy.
“These appointments strengthen our panel of clinical and scientific leaders helping to guide our work as we continue to advance CyPath® Lung as a vital diagnostic tool to detect lung cancer at an early stage in high-risk patients,” said Maria Zannes, President and CEO of bioAffinity Technologies. “Drs. Ost, Sterman, and Ferguson are nationally recognized leaders in pulmonary medicine and lung cancer care. Their advice and counsel will be instrumental as we focus on clinical implementation and broader adoption of our diagnostic platform.”
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the contributions of Drs. Ost, Sterman and Ferguson to the Company and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260209112969/en/
Contact:
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://investors@bioaffinitytech.com
Paulness
6月前
NEWS -- bioAffinity Technologies’ Laboratory Maintains Prestigious College of American Pathologists (CAP) Accreditation
CyPath® Lung addresses urgent unmet need in projected $10.4 billion lung cancer diagnostic market by 2034
Precision Pathology Laboratory Services meets gold standard for excellence across all laboratory service lines
CAP accreditation reaffirms CyPath® Lung test’s highest standards of quality, accuracy and patient safetySAN ANTONIO, January 07, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced that its wholly owned laboratory subsidiary, Precision Pathology Laboratory Services (PPLS), has successfully maintained its accreditation from the College of American Pathologists (CAP) following a rigorous on-site inspection.
Considered the gold standard in laboratory quality, CAP accreditation signifies that a laboratory meets high standards of quality, accuracy and patient safety through comprehensive peer-based inspections conducted every two years.
"Earning CAP accreditation is a significant achievement and a testament to our laboratory team’s commitment to the highest standards in laboratory medicine," said Xavier T. Reveles, MS, Chief Operating Officer of bioAffinity Technologies and PPLS. "This accreditation highlights our dedication to quality, accuracy and patient safety while delivering reliable diagnostic services, including our noninvasive CyPath® Lung test, in support of better patient outcomes. We are proud of our team for consistently exceeding these rigorous standards."
"In September 2023, we acquired PPLS, which generates revenue from anatomic and clinical pathology services and serves as a foundation for the long-term growth of our high-value CyPath® Lung diagnostic test," said Maria Zannes, President and CEO of bioAffinity Technologies. "Our key growth driver, CyPath® Lung can detect lung cancer as early as Stage 1A when treatment can be curative. Physicians are increasingly ordering our test to determine next steps for patient care, and ongoing CAP accreditation supports our value proposition with physicians, health systems and potential partners."
bioAffinity’s CyPath® Lung addresses the urgent unmet need for noninvasive early-stage lung cancer diagnosis. The U.S. lung cancer diagnostics market size was valued at approximately $4.8 billion in 2024. Based on an 8.1% compound annual growth rate, the market is projected to reach $10.4 billion by 2034.1
About CyPath® Lung
CyPath® Lung is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
About Precision Pathology Laboratory Services
Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies, delivers pathology services to physicians practicing in a variety of outpatient settings. In addition to CyPath® Lung, our comprehensive laboratory offerings include anatomic pathology, morphological staining, histological services and molecular testing. PPLS is accredited by the College of American Pathologists (CAP) and certified under the Clinical Laboratory Improvement Amendments (CLIA), ensuring high standards of accuracy and reliability. Visit https://precisionpath.us.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s CyPath® Lung is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit https://www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, risks related to the Company’s technologies and prospects, including but not limited to risks relating to the Company’s ability to maintain CAP accreditation; the Company’s ability to capitalize on the lung cancer diagnostics market projected to reach $10.4 billion by 2034; the ability of CyPath® Lung to identify lung cancer; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
1 Statifacts; U.S. Lung Cancer Diagnostics Market - Databook 2025 to 2034
View source version on businesswire.com: https://www.businesswire.com/news/home/20260107160854/en/
Contacts
bioAffinity Technologies
Julie Anne Overton
Director of Communications
mailto://jao@bioaffinitytech.com
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