US Market News
3週前
CareDx to Participate in Upcoming Investor ConferencesMay 20, 2026 4:01 PM
Business Wire CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the company will participate in the following investor conferences: Jefferies 2026 Global Healthcare Conference at the Marriot Marquis in New York, NY. Presentation on Wednesday, June 3, 2026, at 5:30pm ET. Goldman Sachs 47th Annual Global Healthcare Conference at the Loews Miami Beach Hotel in Miami Beach, FL. Fireside chat on Monday, June 8, 2026, at 1:20pm ET. Live and archived webcasts of the presentations will be available on the “Events and Presentations” section of the CareDx investor relations website at investors.caredx.com. About CareDx CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260520182999/en/ Investor Relations
Caroline Corner
investor@caredx.com Original: CareDx to Participate in Upcoming Investor Conferences
US Market News
1月前
CareDx Announces Dismissal of 2021 Qui Tam SuitMay 11, 2026 4:05 PM
Business Wire CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the dismissal of a qui tam action filed against the Company. On April 23, 2026, the United States District Court for the Eastern District of New York issued an order dismissing the matter. There is no monetary payment associated with the dismissal. The dismissal order follows the request, by the qui tam plaintiff, for dismissal of the case and the Department of Justice's (DOJ) concurrence in that request. The matter was initially filed on February 12, 2021 and led to a DOJ investigation. On October 8, 2024, CareDx announced that the DOJ had concluded its investigation into CareDx without any finding of wrongdoing and declined to take further action. CareDx has denied allegations of wrongdoing throughout. About CareDx CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511565245/en/ CareDx
Media Contacts
Natasha Moshirian Wagner
nwagner@caredx.com Investor Relations
Caroline Corner
investor@caredx.com Original: CareDx Announces Dismissal of 2021 Qui Tam Suit
US Market News
1月前
CareDx Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)May 1, 2026 4:01 PM
Business Wire
CareDx, Inc. (Nasdaq: CDNA), — The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the award of inducement grants.
On April 30, 2026, as an inducement material to acceptance of employment with CareDx, 23 new employees were awarded restricted stock units (RSUs) for an aggregate of 63,856 shares of common stock.
The RSU awards were made pursuant to the Company’s 2019 and 2025 Inducement Equity Incentive Plans in accordance with Nasdaq Listing Rule 5635(c)(4).
The RSUs will vest over four years, with 25% of the RSUs vesting on the first anniversary of each employee’s vesting commencement date, and 1/16th of the RSUs vesting on each date that is three (3) months thereafter subject to each employee’s continued service through each vesting date.
CareDx is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260501877613/en/
CareDx
Media Contacts
Natasha Moshirian Wagner
nwagner@caredx.com
Investor Relations
Caroline Corner
investor@caredx.com
Original: CareDx Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
2月前
CareDx Announces Agreement to Acquire Naveris, A Leader in Viral-Mediated Cancer MRD Surveillance TestingApril 28, 2026 4:05 PM
Business Wire
Transaction extends CareDx’s Precision Medicine Testing Services strategy into specialty oncology with a Medicare-reimbursed commercial-stage MRD test and platform addressing a $4.5 Billion TAM
Estimated 2025 Revenue of $34 Million is expected to grow 30-40% annually for the next three years and neutral to CareDx’s FY2026 Adjusted EBITDA guidance
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced it has entered into a definitive agreement to acquire Naveris, a commercial stage precision oncology diagnostics company with a highly differentiated and Medicare-reimbursed, blood-based monitoring solution for viral-mediated cancers. The transaction is an extension of CareDx’s strategy to focus on its U.S. Precision Medicine Testing Services and Patient and Digital Solutions. The definitive agreement provides for an up-front cash consideration of $160 million with up to an additional $100 million based on the achievement of revenue milestones.
Naveris’ highly differentiated liquid biopsy platform is based on Tumor Tissue Modified Viral (TTMV®) DNA. The platform measures fragments of viral DNA released from tumor tissue into the bloodstream, serving as a highly accurate biomarker in human papillomavirus (HPV)-driven cancers. This tumor-naïve testing is designed to support the management of patients from diagnosis through post-treatment molecular residual disease (MRD) surveillance.
Naveris reported unaudited revenue of $34 million in 2025, which we forecast to grow 30-40% annually for the next three years. For the first quarter of 2026, Naveris reported unaudited revenue of approximately $12 million, gross margins of 65% and net operating loss of $0.2 million. CareDx estimates the transaction will not impact its 2026 AEBITDA guidance and plans to provide further guidance following the close of the transaction.
“Today’s announcement accelerates our growth strategy in Precision Medicine Testing Services and Patient & Digital Solutions. We are focused on being a leader in concentrated specialty markets where a high burden of disease drives repeat testing. Naveris fits that profile with a differentiated technology that is early in its adoption,” said John Hanna, President & CEO of CareDx. “Naveris is poised for strong growth, leveraging our core capabilities—building belief in molecular testing, simplifying clinical workflow, and generating evidence for coverage and reimbursement.”
Naveris employs approximately 100 individuals and has performed more than 130,000 commercial tests to date. The test received Medicare coverage in 2023 and is a leading solution in Head & Neck and Anal cancer MRD surveillance.
“Naveris has developed and commercialized a liquid biopsy monitoring platform proven to detect cancer earlier and with greater accuracy than conventional approaches,” said James B. McNally, Chief Executive Officer of Naveris. “We are thrilled to be combining forces with CareDx to fulfill our mission of improving patient outcomes by delivering disruptive technology that transforms cancer care and expanding patient access to precision medicine.”
The parties anticipate the transaction to close in the third quarter of 2026, subject to customary closing conditions.
Goldman Sachs is acting as the exclusive financial advisor to CareDx in connection with the transaction. Fenwick & West is acting as legal advisor to CareDx. J.P. Morgan Securities LLC is acting as the exclusive financial advisor to Naveris in connection with the transaction. Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal advisor to Naveris.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
About Naveris
A portfolio company of B-FLEXION Life Sciences, Naveris is a privately held, commercial-stage precision oncology diagnostics company focused on improving outcomes for patients with viral-driven cancers. Founded in 2017, the Company develops and commercializes novel molecular diagnostics designed to enable earlier cancer detection and more personalized disease management. Naveris’ proprietary NavDx® test is a clinically validated circulating tumor DNA blood test that detects tumor tissue–modified viral (TTMV®) HPV DNA to support post-treatment surveillance and molecular residual disease (MRD) assessment in HPV-driven cancers. The Company operates high-complexity clinical laboratories in Massachusetts and North Carolina that are accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center and certified under CLIA. For more information, please visit www.naveris.com and www.NavDx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx including statements regarding the expected completion and timing of the acquisition, the anticipated impact of the transaction on CareDx’s business, financial profile, and operating results, the benefits of the Naveris product, reimbursement coverage for the Naveris product, the achievement of CareDx’s financial and operational goals and its expectations and prospects for 2026, the ability of CareDx to advance Naveris’ platform technologies on a timely basis, if at all, the ability to satisfy all closing conditions and complete the transaction, difficulties or unanticipated expenses in connection with integrating the companies, and other statements that are not historical facts. These forward-looking statements are based on information currently available to CareDx and its current expectations, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the failure to obtain required regulatory approvals or satisfy closing conditions, delays in completing the transaction, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these risks may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260428112222/en/
CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com
Investor Relations
Caroline Corner
investor@CareDx.com
Original: CareDx Announces Agreement to Acquire Naveris, A Leader in Viral-Mediated Cancer MRD Surveillance Testing
US Market News
2月前
CareDx Introduces AlloSeq Nano at EFI 2026, Expanding HLA Typing Portfolio with Long-Read SequencingApril 20, 2026 7:05 AM
Business Wire
AlloSeq Nano delivers rapid, high-resolution HLA and ABO genotyping in a single assay through a streamlined, long-read workflow designed for transplant and donor typing laboratories.
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today introduced AlloSeq Nano, a nanopore-based HLA (human leukocyte antigen) and ABO blood type genotyping solution, at the European Federation for Immunogenetics (EFI) Conference 2026.
AlloSeq Nano is an innovation developed by CareDx to deliver high-resolution HLA genotyping in under three hours with streamlined long-read library prep workflow, rapid assay turnaround, robust performance, and enhanced resolution.
In early access testing, Alloseq Nano’s single-step amplification and prep workflow required approximately 45 minutes of hands-on time to assay eleven HLA loci plus ABO in a single test. The assay’s elegant probe redundancy helps minimize allele dropout, while long-read sequencing reduces phasing ambiguities, enhancing overall performance and accuracy.
AlloSeq Nano expands CareDx’s pre-transplant Lab Products portfolio, alongside AlloSeq Tx and QTYPE®, to support a broader range of laboratory throughput requirements and use cases.
To introduce AlloSeq Nano, CareDx will host a satellite symposium at EFI 2026 on Thursday, April 23, from 13:00–14:00 BST, at the Edinburgh Congress Centre, Sidlaw Auditorium. The symposium will feature scientific and educational discussions related to AlloSeq Nano and CareDx’s transplant diagnostics portfolio.
CareDx will also present multiple abstracts at EFI 2026 reflecting scientific engagement across laboratory, clinical, and technical dimensions of transplant diagnostics. Accepted abstracts include presentations featuring AlloSeq cfDNA in kidney and lung transplant settings, as well as a presentation featuring QTYPE®, highlighting rapid ABO genotyping in combination with HLA typing.
Lab Products Business Update
CareDx announced on April 15, 2026 that it entered into a definitive agreement to divest its Lab Products business to EuroBio Scientific, which is expected to close by the end of the third quarter of 2026. CareDx’s Lab Products business consists of IVD (in vitro diagnostic) PCR kits for rapid deceased donor HLA (human leukocyte antigen) typing, IVD NGS-based (next-generation sequencing) kits for transplant recipient HLA typing globally, including AlloSeq Nano; and IVD NGS-based monitoring assays for solid organ and stem cell transplant recipients outside of North America.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx including statements regarding the potential benefits and results that may be achieved with AlloSeq Nano. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSeq Nano, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
AlloSeq Nano, AlloSeq cfDNA, and QTYPE are available as CE-IVD and Research Use Only (RUO). RUO products are not to be used for diagnostic procedures. For local regulatory status, please contact CareDx. AlloSeq is a trademark or registered trademark of CareDx Inc. or its subsidiaries in the US or other countries. AlloSeq is a registered trademark with the US Patent and Trademark Office. © 2026 CareDx, Inc. All service marks or trademarks are owned or licensed by CareDx, Inc. or its affiliates. All rights reserved.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260420549411/en/
CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com
Investor Relations
Caroline Corner
investor@CareDx.com
Original: CareDx Introduces AlloSeq Nano at EFI 2026, Expanding HLA Typing Portfolio with Long-Read Sequencing
US Market News
2月前
CareDx Announces Agreement to Divest Lab Products Business to EuroBio Scientific for $170 Million and Announces First Quarter Preliminary Financial ResultsApril 15, 2026 4:30 PM
Business Wire
Transaction Expected to Sharpen CareDx’s Focus on Core Precision Medicine Testing Services and Patient and Digital Solutions, Improve Financial Flexibility, Simplify Operating Model, and Support AEBITDA Margin Expansion
Expects First Quarter Testing Services Revenue Growth of Approximately 48% Year Over Year, Testing Volume Growth of Approximately 17% Year-Over-Year
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced that it has entered into a definitive agreement to divest its Lab Products business to EuroBio Scientific for cash consideration of $170 million. The transaction has been approved by the boards of directors of both companies. CareDx also announced today preliminary financial results for the first quarter of 2026.
CareDx’s Lab Products business consists of IVD (in vitro diagnostic) PCR kits for rapid deceased donor HLA (human leukocyte antigen) typing, IVD NGS-based (next-generation sequencing) kits for transplant recipient HLA typing globally, and IVD NGS-based monitoring assays for solid organ and stem cell transplant recipients outside of North America. As a global IVD kit business with distinct manufacturing, regulatory, and commercial requirements, Lab Products operates under a different model than CareDx’s core U.S.-based Precision Medicine Testing Services and its Patient and Digital Solutions. The divestiture is intended to simplify CareDx’s operating model and support disciplined capital redeployment toward opportunities aligned with its Precision Medicine Testing Services model.
“This divestiture allows us to strategically focus on our core Testing Services and Patient and Digital Solutions, where our solutions-selling strategy is working. In the first quarter, these segments delivered 48% and 33% year-over-year revenue growth, respectively,” said John Hanna, President and CEO of CareDx. “Having partnered with EuroBio Scientific since 2014, we believe their global scale and broad IVD capabilities positions them well to execute the Lab Products business and continue providing the highest quality service to our IVD customers and patients worldwide.”
Highlighted Terms of the Agreement
CareDx to divest its Lab Products business to EuroBio Scientific
Total consideration of $170 million in cash at closing
CareDx to provide transition services to EuroBio Scientific for at least 6-months at EuroBio Scientific’s expense
EuroBio Scientific grants to CareDx the sole and exclusive perpetual right to distribute post-transplant monitoring IVD tests in North America, including AlloSeq cfDNA, CareDx’s IVD kit version of its market-leading AlloSure dd-cfDNA CLIA test
The company expects to apply a disciplined approach to capital allocation consistent with its track record. Proceeds from the transaction are expected to be prioritized toward investments that support CareDx’s long-term growth strategy, including potential inorganic investments that fit its Precision Diagnostics Solutions model, and may also include the return of capital to shareholders.
The transaction, including the sale of CareDx’s Swedish entity, requires Swedish regulatory review. The parties anticipate the transaction to close by the end of CareDx’s third quarter, 2026.
Separately, CareDx is providing the following preliminary results for the first quarter of 2026 in advance of its scheduled quarterly reporting process.
Preliminary First Quarter 2026 Financial Results
Revenue of approximately $118 million, growth of 39% year-over-year
Testing Service Volume of approximately 54,900, growth of 17% year–over-year
Testing Service revenue of approximately $91 million, growth of 48% year–over-year,
Average revenue per test of approximately $1,660 including approximately $14 million in prior period revenue
Patient and Digital Solutions revenue of approximately $16 million, growth of 33% year-over-year
Lab Products revenue of approximately $10 million, decline of 4% year-over-year
Cash, cash equivalents, and marketable securities of approximately $198 million as of March 31, 2026
The preliminary financial information presented in this press release is based on CareDx’s current expectations and may be adjusted as a result of, among other things, the completion of customary procedures. The company anticipates providing further guidance during its first quarter 2026 earnings call on April 28, 2026.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
About EuroBio Scientific
Eurobio Scientific is a major player in the field of specialty in vitro diagnostics. It is involved in everything from research to the marketing of diagnostic tests in the fields of transplantation, immunology, and infectious diseases, and offers reagents for research laboratories, including pharmaceutical and biotechnology companies. With its numerous partnerships and strong hospital presence, Eurobio Scientific has its own extensive distribution network and a portfolio of proprietary products. For further information, visit: www.eurobio-scientific.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx including statements regarding the expected completion and timing of the divestiture, the anticipated impact of the transaction on CareDx’s business, financial profile, and operating results, the expected use of proceeds, the achievement of CareDx’s financial and operational goals and its expectations and prospects for 2026, and other statements that are not historical facts. These forward-looking statements are based on information currently available to CareDx and its current expectations, and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, the failure to obtain required regulatory approvals or satisfy closing conditions, delays in completing the transaction, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these risks may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260415770733/en/
CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com
Investor Relations
Caroline Corner
investor@CareDx.com
Original: CareDx Announces Agreement to Divest Lab Products Business to EuroBio Scientific for $170 Million and Announces First Quarter Preliminary Financial Results
US Market News
2月前
CareDx to Report First Quarter 2026 Financial Results on April 28, 2026April 14, 2026 4:01 PM
Business Wire
CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced it will report financial results for the first quarter 2026 after market close on Tuesday, April 28, 2026. The Company will host a webcast and conference call that day at 1:30 p.m. PT / 4:30 p.m. ET.
A live and archived webcast of the conference call can be accessed on the Events & Presentations section of CareDx’s Investor Relations website at investors.caredx.com. To participate in the live conference call via telephone, register here. Upon registering, a dial-in number and unique PIN will be provided.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260414339796/en/
Investor Contact
investor@caredx.com
Original: CareDx to Report First Quarter 2026 Financial Results on April 28, 2026
US Market News
3月前
CareDx Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)February 27, 2026 4:01 PM
Business Wire
CareDx, Inc. (Nasdaq: CDNA), — The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the award of inducement grants.
On February 24, 2026, as an inducement material to acceptance of employment with CareDx, 35 new employees were awarded restricted stock units (RSUs) for an aggregate of 82,137 shares of common stock.
The RSU awards were made pursuant to the Company’s 2016 and 2025 Inducement Equity Incentive Plans in accordance with Nasdaq Listing Rule 5635(c)(4).
The RSUs will vest over four years, with 25% of the RSUs vesting on the first anniversary of each employee’s vesting commencement date, and 1/16th of the RSUs vesting on each date that is three (3) months thereafter subject to each employee’s continued service through each vesting date.
CareDx is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).
View source version on businesswire.com: https://www.businesswire.com/news/home/20260227366737/en/
CareDx
Media Contacts
Natasha Moshirian Wagner
nwagner@caredx.com
Investor Relations
Caroline Corner
investor@caredx.com
Original: CareDx Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
4月前
CareDx Announces Appointment of Keith Kennedy as Chief Operating Officer and Chief Financial OfficerFebruary 24, 2026 5:15 PM
Business Wire
Kennedy brings seven years of public company CFO experience
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced that Keith Kennedy, the Company’s Chief Operating Officer (COO), will also assume the responsibilities of Chief Financial Officer (CFO) and oversee the Company’s finance organization effective February 26, 2026.
Kennedy brings to CareDx over 20 years of experience and executive leadership in healthcare including global diagnostics, biopharma services, and contract development and manufacturing organization (CDMO). Kennedy has served as our Chief Operating Officer since September 2024. Prior to joining us, Kennedy served as CFO at PharmaLogic Holdings Corp from April 2022 to September 2024. At Veracyte, Kennedy served in various roles from December 2016 to May 2021, including as COO, CFO, and Secretary. Kennedy also held key executive positions at MCG Capital Corporation and GE Capital. He served as an Officer in the U.S. Air Force. Kennedy received a B.S. in Accounting with high distinction from Indiana University and an M.B.A. from the College of William & Mary. Kennedy is a Chartered Financial Analyst and Certified Public Accountant.
Nathan Smith announced on the company’s quarterly earnings call that he will be stepping down from his role as CFO.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including general economic and market factors and other risks discussed in CareDx’s filings with the SEC, including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2025 to be filed by CareDx with the SEC on February 25, 2026, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260224533991/en/
CareDx
Media Contacts
Natasha Moshirian Wagner
nwagner@caredx.com
Investor Relations
Caroline Corner
investor@caredx.com
Original: CareDx Announces Appointment of Keith Kennedy as Chief Operating Officer and Chief Financial Officer
US Market News
4月前
CareDx Announces Clinical Validation Results for AlloHeme™, the First AI-Powered NGS Surveillance Solution for AML and MDS Post-Cell TherapyFebruary 12, 2026 7:05 AM
Business Wire
AlloHeme Identified Cancer Relapse Earlier Than Standard Monitoring Methods in AML and MDS Patients Following Allogeneic HCT
Ultra-Sensitive, Non-Invasive Surveillance Solution Expected to Launch Commercially in the U.S. in 2027 as Part of CareDx’s Transplant+ Precision Medicine Portfolio
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced pivotal clinical validation results of AlloHeme™, a non-invasive, next-generation sequencing (NGS)–based, and artificial intelligence (AI)-powered monitoring test designed to predict relapse in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) following allogeneic hematopoietic cell transplant (HCT). This approach enables the detection of emerging relapse signals earlier than traditional bone marrow-based or marker-specific methods, offering a universal, ultra-sensitive, blood-based surveillance solution for post-HCT AML and MDS patients. The data, generated as part of the ACROBAT study (NCT04635384), were presented at the 2026 Tandem Meetings and will also be reviewed alongside commercial launch plans during CareDx’s investor webcast on February 12, 2026, at investors.caredx.com.
The successful clinical validation of AlloHeme represents a key milestone in CareDx’s Transplant+ strategy, expanding the Company’s precision medicine capabilities into cell therapy, hematology, and oncology by enabling highly sensitive, tumor-naive surveillance for relapse following HCT in patients with AML and MDS. By addressing a major gap in post-HCT relapse monitoring for AML and MDS patients, this initiative broadens CareDx’s impact beyond solid organ transplantation and into areas of growing clinical need.
“Cancer relapse remains a leading cause of mortality in patients with AML and MDS post allogeneic hematopoietic cell transplantation,” said Dr. Jeff Teuteberg, MD, CareDx Chief Medical Officer. “AlloHeme represents the next wave of innovation within CareDx’s Transplant+ strategy as we expand from solid organ transplantation into cell therapy, by providing clinicians with a highly sensitive, blood-based tool that can help identify relapse earlier. The ACROBAT data highlight the potential clinical value this test offers physicians, patients, and cell therapy centers. We are excited to bring this innovative technology to market in a capacity that only CareDx offers – alongside a full suite of patient and digital solutions for the cell therapy community.”
The ACROBAT study is a prospective, multi-center, observational trial conducted across 11 U.S. transplant centers. The 24-month analysis included 198 evaluable subjects and 40 relapse events. AlloHeme demonstrated strong clinical performance, including 85% sensitivity and 92% specificity. This translated to a 95% negative predictive value, 79% positive predictive value, and an area under the curve of 0.89. The assay identified relapse a median of 41 days before clinical detection. At 6 months post-transplant, patients with positive AlloHeme results showed a 12-fold higher relapse risk compared to patients with negative AlloHeme results (p
US Market News
4月前
CareDx to Present AlloHeme™ Pivotal Clinical Validation Data in Hematologic Cancer Relapse Detection at 2026 Tandem MeetingsFebruary 3, 2026 9:54 AM
Business Wire
Company to host investor webcast and conference call on February 12 at 7 a.m. PT / 10 a.m. ET
Investor webcast will feature the clinical validation data and review commercial launch timeline
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced that pivotal clinical validation data from the ACROBAT study (NCT04635384) will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR®, held February 4-7, 2026, in Salt Lake City, Utah.
The ACROBAT study is a prospective, multi-center, blinded clinical trial evaluating AlloHeme, CareDx’s AI-powered next-generation sequencing (NGS)-based peripheral blood test for monitoring relapse after allogeneic hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. AlloHeme identifies cancer relapse ahead of traditional detection methods, potentially enabling timely clinical interventions. The ACROBAT study includes patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) monitored with AlloHeme for cancer relapse at 11 hematopoietic stem cell transplant centers across the U.S.
The oral presentation will feature the complete 24-month follow-up results, building upon 18-month interim results published in the conference abstract, available online here.
In addition, on February 12, 2025, CareDx will host an investor webcast and conference call to discuss the study findings and commercial launch timeline.
Tandem Presentation Details:
Presentation ID 61: Acrobat Interim Results: Peripheral Blood-Based AlloHeme Test Enables Robust Relapse Surveillance in Post-HCT AML and MDS Patients
Presenter: Dr. Ran Reshef, Professor of Medicine at Columbia University and Director of Translational Research, Blood and Marrow Transplantation Program at Herbert Irving Comprehensive Cancer Center
Date & Time: Friday, February 6, 3:15 p.m. MT
Location: Ballroom I, Salt Palace Convention Center
Investor Webcast Details:
Presentation: AlloHeme Clinical Validation Data Review and Launch Timeline
Date & Time: Thursday, February 12, 7 a.m. PT / 10 a.m. ET
The one-hour event will feature presentations by members of the CareDx’s leadership team and ACROBAT study site Principal Investigator, Dr. Ran Reshef.
A live and archived webcast can be accessed on the Events & Presentations section of CareDx’s Investor Relations website at investors.caredx.com. To participate in the live conference call via telephone, register here. Upon registering, a dial-in number and unique PIN will be provided.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx including statements regarding the potential benefits and results that may be achieved with AlloHeme. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloHeme are, risks that the findings in the ACROBAT study supporting the data may be inaccurate, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed by CareDx with the SEC on November 4, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260203634748/en/
CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com
Investor Relations
Caroline Corner
investor@CareDx.com
Original: CareDx to Present AlloHeme™ Pivotal Clinical Validation Data in Hematologic Cancer Relapse Detection at 2026 Tandem Meetings
US Market News
4月前
CareDx to Present AlloHeme™ Pivotal Clinical Validation Data in Hematologic Cancer Relapse Detection at 2026 Tandem MeetingsFebruary 3, 2026 7:05 AM
Business Wire
Company to host investor webcast and conference call on February 12 at 7 a.m. PT / 10 a.m. ET
Investor webcast will feature the clinical validation data and review commercial launch timeline
CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced that pivotal clinical validation data from the ACROBAT study (NCT04635384) will be presented at the 2026 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ASTCT™ and CIBMTR®, held February 4-7, 2026, in Salt Lake City, Utah.
The ACROBAT study is a prospective, multi-center, blinded clinical trial evaluating AlloHeme, CareDx’s AI-powered next-generation sequencing (NGS)-based peripheral blood test for monitoring relapse after allogeneic hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. AlloHeme identifies cancer relapse ahead of traditional detection methods, potentially enabling timely clinical interventions. The ACROBAT study includes patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) monitored with AlloHeme for cancer relapse at 11 hematopoietic stem cell transplant centers across the U.S.
The oral presentation will feature the complete 24-month follow-up results, building upon 18-month interim results published in the conference abstract, available online here.
In addition, on February 12, 2025, CareDx will host an investor webcast and conference call to discuss the study findings and commercial launch timeline.
Tandem Presentation Details:
Presentation ID 61: Acrobat Interim Results: Peripheral Blood-Based AlloHeme Test Enables Robust Relapse Surveillance in Post-HCT AML and MDS Patients
Presenter: Dr. Ran Reshef, Professor of Medicine at Columbia University and Director of Translational Research, Blood and Marrow Transplantation Program at Herbert Irving Comprehensive Cancer Center
Date & Time: Friday, February 6, 3:15 p.m. MT
Location: Ballroom I, Salt Palace Convention Center
Investor Webcast Details:
Presentation: AlloHeme Clinical Validation Data Review and Launch Timeline
Date & Time: Wednesday, February 12, 7 a.m. PT / 10 a.m. ET
The one-hour event will feature presentations by members of the CareDx’s leadership team and ACROBAT study site Principal Investigator, Dr. Ran Reshef.
A live and archived webcast can be accessed on the Events & Presentations section of CareDx’s Investor Relations website at investors.caredx.com. To participate in the live conference call via telephone, register here. Upon registering, a dial-in number and unique PIN will be provided.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
Forward Looking Statements
This press release includes forward-looking statements related to CareDx including statements regarding the potential benefits and results that may be achieved with AlloHeme. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloHeme are, risks that the findings in the ACROBAT study supporting the data may be inaccurate, general economic and market factors, and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed by CareDx with the SEC on February 28, 2025, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed by CareDx with the SEC on November 4, 2025, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260203634748/en/
CareDx, Inc.
Media
Natasha Moshirian Wagner
nwagner@CareDx.com
Investor Relations
Caroline Corner
investor@CareDx.com
Original: CareDx to Present AlloHeme™ Pivotal Clinical Validation Data in Hematologic Cancer Relapse Detection at 2026 Tandem Meetings
US Market News
4月前
CareDx to Participate in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference January 27, 2026 9:05 PM
Business Wire
CareDx, Inc. (Nasdaq: CDNA) - The Transplant Company™ —, a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the company will participate in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, UT on Tuesday, February 10, 2026.
About CareDx
CareDx is a precision medicine company dedicated to improving outcomes for transplant patients and advancing organ health. The Company’s integrated solutions include non-invasive molecular testing for heart, kidney, and lung transplants; laboratory products; digital health technologies; and patient solutions that support care before and after transplant. CareDx is the leading provider of genomics-based information for transplant patients. For more information, please visit www.caredx.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260127761296/en/
Investor Relations
Caroline Corner
investor@caredx.com
Original: CareDx to Participate in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference
subslover
3年前
CareDx Reports Third Quarter 2023 Results
BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) — The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers — today reported financial results for the third quarter ended September 30, 2023.
Third Quarter 2023 Highlights
Reported revenue of $67.2 million, an increase of 7% over the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue.
Grew Testing Services patient results to 38,400, an increase of 2% compared to the second quarter of 2023.
Achieved revenue of $9.9 million for Digital Solutions and $9.5 million for Products, representing year-over-year growth of 33% for both businesses.
Achieved the fourth consecutive quarter of collections at over 100% of revenue for Testing Services; collected over $22 million in incremental cash in the past four quarters.
Maintained a strong balance sheet, with $268.2 million in cash and cash equivalents, and marketable securities, with no debt.
Received Medicare coverage for HeartCare™ and AlloSure® Lung.
Raised revenue guidance to $274 to $278 million for the full year 2023.
SEC has concluded its inquiry and does not intend to recommend an enforcement action against the Company.
“CareDx continues to be well-placed in the transplant market. We are pleased to see a baseline being set in the Testing Services business in Q3 as patient testing volumes appear to have stabilized,” said Alex Johnson, President of Patient and Testing Services, and member of the Office of the CEO at CareDx. “We remain committed to bringing high impact innovation to the transplant clinic, while accelerating our path back to profitability.”
Third Quarter 2023 Financial Results
Revenue for the three months ended September 30, 2023, was $67.2 million, a decrease of 15% compared with $79.4 million in the third quarter of 2022, and an increase of 7% compared with $62.5 million in the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue. Testing services revenue for the quarter was $47.8 million, compared with $64.8 million in the same period in 2022.
Approximately 38,400 AlloSure® and AlloMap® patient results were provided in the quarter, representing a decrease of 18% as compared to the same quarter a year ago, and an increase of 2% compared to the second quarter of 2023.
For the third quarter of 2023, net loss was $23.5 million, compared to a net loss of $16.9 million in the same period of 2022. Basic and diluted net loss per share in the third quarter of 2023 was $0.43, compared to basic and diluted net loss per share of $0.32 in the third quarter of 2022.
Non-GAAP net loss was $9.6 million in the third quarter of 2023, compared to a non-GAAP net loss of $3.4 million in the third quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.18 in the third quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.06 in the third quarter of 2022.
Adjusted EBITDA for the third quarter of 2023 was a loss of $10.9 million, compared to an adjusted EBITDA loss of $2.5 million in the third quarter of 2022.
Cash and cash equivalents and marketable securities were $268.2 million as of September 30, 2023.
2023 Guidance
For the full year 2023, CareDx expects revenue to be in the range of $274 to $278 million.
About CareDx – The Transplant Company™
CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.
Forward-Looking Statements
This press release includes forward-looking statements, including statements regarding CareDx’s 2023 revenue expectations and the company’s path towards growth. All statements other than statements of historical fact contained in this press release, including statements regarding the future financial position of CareDx, including financial expectations, business strategy and plans and objectives for future operations, are forward-looking statements.
TREND1
9年前
CareDx, Inc. (Nasdaq:CDNA), a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients, today announces that CMS released the 2018 Clinical Laboratory Fee Schedule confirming that the AlloMap reimbursement rate will be increased to $3,240.
The Center for Medicare and Medicaid Services (CMS) released the final 2018 Clinical Laboratory Fee Schedule (CLFS) today, re-affirming the preliminary rate for AlloMap of $3,240, an increase of 14% compared with the 2017 CMS CLFS rate of $2,840.75. The higher 2018 reimbursement rate for AlloMap was due in part to effective claims management, which increased the weighted median of commercial reimbursement. This data was shared with CMS as required by regulations associated with the Protecting Access to Medicare Act of 2014 (PAMA). The effective date of the increase is January 1, 2018.
“The implementation of PAMA by CMS provides a refreshing predictability to the reimbursement of diagnostic tests,” said Sasha King, Chief Commercial Officer at CareDx. “The updated rate highlights the value AlloMap brings to heart transplant patients.”
About CareDx
CareDx, Inc., headquartered in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant recipients. CareDx offers products across the transplant testing continuum, including AlloMap® and AlloSure™ for post-transplant surveillance and Olerup SSP®, Olerup QTYPE®, and Olerup SBT™ for pre-transplant HLA testing.
For more information, please visit: www.CareDx.com.
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