Guardant Health Inc【GH】株式ニュース

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Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer Screening

Updated United policy coverage from the largest commercial insurer in the U.S. means 100 million total covered lives have access to the...

Form 4 - Statement of changes in beneficial ownership of securities

Form 144 - Report of proposed sale of securities

US Market News 1週前

UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer ScreeningJuly 1, 2026 2:50 PM
Business Wire Updated United policy coverage from the largest commercial insurer in the U.S. means 100 million total covered lives have access to the FDA-approved Shield blood test for colorectal cancer (CRC) screening Shield is the first and only FDA-approved blood test included in both ACS and NCCN guidelines With rising rates of CRC in younger people, the first major commercial insurer in the U.S. expands Shield coverage to eligible policyholders aged 45 or older Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its Shield™ blood test for colorectal cancer screening (CRC) is now covered for eligible UnitedHealth Group (UHG) members1, making it the first major commercial insurer to provide coverage for adults 45 or older amid rising CRC rates for adults under 652 and mortality for younger adults as the leading cause of cancer death for those under 50.3 Shield is the first and only FDA-approved blood test for primary colorectal cancer screening in average-risk adults age 45 and older and can be completed with just a blood draw during a routine doctor’s visit, offering Americans a more accessible screening option that overcomes the barriers associated with traditional methods. Approximately 40 million Americans are covered by UHG’s plans, including members under employer and individual plans, beneficiaries covered by Medicare Advantage and individuals with supplemental Medicare coverage. The updated policy coverage from UHG offers those above the age of 45 and at average risk of colorectal cancer access to the latest innovation in colorectal cancer screening. “More than 100 million people across America now have access to the Shield blood test,” said AmirAli Talasaz, Guardant Health co-CEO. “With the rising rates of colorectal cancer in younger people, expanding Shield coverage through United, the nation’s largest commercial health insurer, to the 45+ population as a primary screening option marks a critical milestone in our commercial expansion to make colorectal cancer screening more accessible.” Demonstrating strong clinical performance and real-world evidence published in the New England Journal of Medicine (NEJM),4 Shield is the only FDA-approved blood test included in both ACS5 and National Comprehensive Cancer Network (NCCN) guidelines.6 About Shield Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. ____________________ 1 UnitedHealthcare. Molecular Oncology Testing for Cancer – Commercial and Individual Exchange Medical Policy. Accessed online July 1, 2026. https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/molecular-oncology-testing-for-cancer-08012026.pdf 2 American Cancer Society. Colorectal Cancer Drops in Older Adults and Rises in Younger Ones. Accessed online July 1, 2026. https://www.cancer.org/research/acs-research-news/colorectal-cancer-drops-in-older-adults-and-rises-in-young-ones.html 3 Scientific American. Colon cancer is killing more young people in the U.S. than any other cancer. January 22, 2026. https://www.scientificamerican.com/article/colon-cancer-is-killing-more-young-people-in-the-u-s-than-any-other-cancer/ 4 Chung, D. C., Gray, D. M., II, Singh, H., Issaka, R. B., Raymond, V. M., Eagle, C., Hu, S., et al. (2024). A cell-free DNA blood-based test for colorectal cancer screening. New England Journal of Medicine, 390(11), 973–983. https://doi.org/10.1056/NEJMoa2304714 5 Guardant Health. American Cancer Society Recommends Guardant Health's Shield Blood Test in Updated Colorectal Cancer Screening Guidelines. Accessed online July 1, 2026. https://investors.guardanthealth.com/press-releases/press-releases/2026/American-Cancer-Society-Recommends-Guardant-Healths-Shield-Blood-Test-in-Updated-Colorectal-Cancer-Screening-Guidelines/default.aspx 6 Guardant Health. National Comprehensive Cancer Network (NCCN) Updates Colorectal Cancer Screening Guidelines to Include Shield Blood-Based Screening. Accessed online July 1, 2026. https://investors.guardanthealth.com/press-releases/press-releases/2025/National-Comprehensive-Cancer-Network-NCCN-Updates-Colorectal-Cancer-Screening-Guidelines-to-Include-Shield-Blood-Based-Screening/default.aspx View source version on businesswire.com: https://www.businesswire.com/news/home/20260701277599/en/ Investor Contact:
Zarak Khurshid
investors@guardanthealth.com Media Contact:
Meaghan Smith
press@guardanthealth.com Original: UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer Screening

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ranchhand71 1週前

Bernstein analyst raises 12 month target to $175. If JNJ or Roche are considering GH acquisition they will probably make offer before GH turns profitable at the corporate level IMHO. Upside to $250 if a deal is offered next 12 months?

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US Market News 4週前

Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®June 11, 2026 8:05 AM
Business Wire Blood-based liquid biopsy test enables identification of patients eligible for treatment with HERNEXEOS® (zongertinib tablets) Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) for Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option. The approval enables Guardant360 CDx, a liquid biopsy test that analyzes circulating tumor DNA (ctDNA) from a simple blood draw, to identify patients with HER2 (ERBB2) tyrosine kinase domain activating mutations who may be eligible for treatment with HERNEXEOS. HERNEXEOS is indicated for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. More information and full prescribing information can be found at HERNEXEOS.com. “This approval highlights the growing impact of liquid biopsy across advanced cancer care and underscores the utility of Guardant360 CDx to ensuring more patients can be matched to the right therapy at the right time,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Guardant360 CDx has been at the forefront of enabling comprehensive genomic profiling through a simple blood draw, helping clinicians identify actionable mutations in genes such as HER2 with speed and accuracy.” Guardant360 CDx was the first FDA-approved liquid biopsy that provides comprehensive genomic profiling across multiple tumor types and biomarkers. By detecting tumor-derived alterations in circulating cell-free DNA, the test helps clinicians match patients to appropriate targeted therapies and clinical trials. “Companion diagnostics are essential to personalized lung cancer care, guiding biomarker-driven treatment decisions,” added Vicky Brown, U.S. Therapeutic Area Head for Oncology and Emerging Areas, Boehringer Ingelheim. “Guardant360 CDx will help identify patients with HER2-mutant advanced non-small cell lung cancer and connect eligible patients to the appropriate targeted therapy when timely treatment decisions matter most.” NSCLC is the most common type of lung cancer, and a subset of patients harbor HER2 mutations that may be targetable with precision therapies. HER2-mutant NSCLC is an aggressive type of lung cancer that has been associated with a poor prognosis. Blood-based testing offers a faster, less invasive alternative to tissue biopsy, which can be challenging in advanced disease. This latest FDA approval for Guardant360 CDx marks the 27th CDx indication across multiple tumor types globally, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives. For more information about Guardant360 CDx, visit www.guardanthealth.com. About Guardant360® CDx Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260610919127/en/ Investor Contact:
Zarak Khurshid
investors@guardanthealth.com Media Contact:
Meaghan Smith
press@guardanthealth.com Original: Guardant Health Announces FDA Approval of Guardant360 CDx as Companion Diagnostic for Boehringer Ingelheim’s HERNEXEOS®

American Cancer Society Recommends Guardant Health’s Shield Blood Test in Updated Colorectal Cancer Screening GuidelinesMay 27, 2026 7:47 AM
Business Wire Updated ACS guideline offers Shield as a new choice for over 50 million eligible Americans who are not up to date with their colorectal cancer screening Shield is the first and only FDA-approved blood test included in both ACS and NCCN guidelines Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced that its FDA-approved Shield™ blood test is now included in updated American Cancer Society (ACS) Colorectal Cancer (CRC) Screening Guidelines published today. The major screening guideline update recommends Shield as a choice for patients who decline or have not completed stool-based or visual examination screening tests. In an effort to address persistent screening gaps and rising CRC rates in adults under 65, ACS guidelines now recommend Shield blood-based CRC screening as a new option to expand access and screening participation. Shield is the first and only FDA-approved blood test for primary colorectal cancer screening in average-risk adults age 45 and older and can be completed with just a blood draw during a routine doctor’s visit. CRC is the second leading cancer killer in the United States1 and the number one cancer killer for adults under 50.2 The inclusion of Shield in the updated guidelines acknowledges a central challenge in colorectal cancer screening: more than 50 million eligible adults3 remain unscreened despite established methods like colonoscopy or stool-based testing existing for decades. By recognizing the effectiveness of a blood-based option, the updated guidelines add a new opportunity to reach patients who might otherwise go unscreened. With three out of four CRC deaths among those not up to date with screening4, the American Cancer Society noted that “offering multiple, recommended screening options supports informed patient choice and may improve participation, because the most effective screening test is the one that the patient completes.” “The inclusion of Shield in the American Cancer Society’s guidelines as a recommended option is a momentous step forward in our collective work to reach the more than 50 million Americans who remain unscreened for colorectal cancer,” said AmirAli Talasaz, Guardant Health co-CEO. “We know that tragically cancer does not wait. The Shield blood test has been proven to be effective in detecting cancers and increasing screening participation in the real-world setting. By making colorectal cancer screening more accessible with a blood-based option in conjunction with other established methodologies, we can get people screened.” Guardant’s Shield blood test stood out in guideline evidence for having the highest screening adherence rate compared to traditional colonoscopies and stool-based tests.5 In the real-world experience with approximately 200,000 patients tested, Shield is proven to increase screening rates with over 90% of patients completing the test.6 In the pivotal ECLIPSE study, Shield showed its high sensitivity in detecting colorectal cancers and demonstrated sensitivity of 100% in detecting stage II and above cancers.7 “Screening rates have been largely stagnant across the population, with particular challenges in delivering screening to younger individuals age 45 to 55, racial and ethnic minoritized groups, and individuals with lower socioeconomic position. By providing the choice of a new CRC screening modality, blood-based testing has the potential to expand the reach of CRC screening to individuals who might otherwise remain unscreened,” said Samir Gupta, MD, Professor of Medicine at the University of California San Diego. “Today’s guideline update reflects the continued evolution of CRC screening-related technological advances, outlines persistent gaps in screening participation, and the potential for advances like blood-based testing to increase screening uptake.” Demonstrating strong real-world evidence and clinical performance published in the New England Journal of Medicine (NEJM)7, Shield is the only FDA-approved blood test included in both ACS and National Comprehensive Cancer Network (NCCN) guidelines. “The new ACS guidelines recognize that colorectal cancer screening is not one size fits all. Patients have several screening options, and their choices are impacted by where they live, their access to care, financial pressures, personal preferences, and individual risk factors,” said Anjee Davis, MPPA, CEO at Fight Colorectal Cancer. “As options expand, Fight CRC remains committed to patients making an informed choice, providing clear education, and ensuring timely follow up so more people can complete lifesaving screening. Our shared goal is clear: achieving 80% screening rates in every community.” “Presenting patients with options helps them make educated health decisions,” said Chris Evans, President of the Colon Cancer Coalition. “The introduction of a blood-based choice for colorectal cancer screening will increase screening rates and ultimately save lives.” ACS guidelines for colorectal cancer screening were last updated in 2018 to lower the recommended age for screening for adults at average risk from 50 to 45 in response to the rising rate of CRC among younger adults. About Shield Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. 1 American Cancer Society. Key Statistics for Colorectal Cancer. Accessed online February 9, 2026. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html 2 Scientific American. Colon cancer is killing more young people in the U.S. than any other cancer. January 22, 2026. https://www.scientificamerican.com/article/colon-cancer-is-killing-more-young-people-in-the-u-s-than-any-other-cancer/ 3 American Cancer Society National Colorectal Cancer Roundtable. Colorectal Cancer Is A Major Public Health Problem. https://nccrt.org/our-impact/data-and-progress/. 4 Doubeni, C, et al. Modifiable Failures in the Colorectal Cancer Screening Process and Their Association with Risk of Death. Gastroenterology. 2019 Jan; 156(1): 63–74.e6. 5 Cullison J. A blood-based test for colorectal cancer screening. HCA Healthc J Med. 2025;6(6):571-573. doi:10.36518/2689-0216.2259. 6 Graham-Adderton, C., Guerra, C. E., Ngo-Metzger, Q., Hoang, T., & Raymond, V. M. (2025). Implementation of blood-based colorectal cancer screening: Real-world adherence and outcomes. 7 Chung, D. C., Gray, D. M., II, Singh, H., Issaka, R. B., Raymond, V. M., Eagle, C., Hu, S., et al. (2024). A cell-free DNA blood-based test for colorectal cancer screening. New England Journal of Medicine, 390(11), 973–983. https://doi.org/10.1056/NEJMoa2304714 View source version on businesswire.com: https://www.businesswire.com/news/home/20260526499046/en/ Investor Contact:
Zarak Khurshid
investors@guardanthealth.com Media Contact:
Meaghan Smith
press@guardanthealth.com Original: American Cancer Society Recommends Guardant Health’s Shield Blood Test in Updated Colorectal Cancer Screening Guidelines

Guardant Health Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)May 18, 2026 4:51 PM
Business Wire Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that on April 21, 2026, the Compensation Committee of Guardant’s Board of Directors approved the granting of restricted stock units (“RSUs”) representing 143,898 shares of its common stock to 267 new non-executive employees with a grant date of May 11, 2026 under the Guardant Health, Inc. 2023 Employment Inducement Incentive Award Plan (the “Inducement Plan”). The RSUs were granted as inducements material to the employees entering into employment with Guardant in accordance with Nasdaq Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Guardant, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Guardant, pursuant to Nasdaq Listing Rule 5635(c)(4). One-third of the shares underlying each RSU award vest on an annual basis on the anniversary of the vesting commencement date, subject to each employee’s continued employment with Guardant as of each such vesting date. The RSUs are subject to the terms and conditions of the Inducement Plan and the terms and conditions of a RSU award agreement covering the grant. About Guardant Health Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. Guardant Health Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release. View source version on businesswire.com: https://www.businesswire.com/news/home/20260518970043/en/ Investor Contact:
Zarak Khurshid
investors@guardanthealth.com Media Contact:
Meaghan Smith
press@guardanthealth.com Original: Guardant Health Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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US Market News 2月前

Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 MutationsMay 4, 2026 8:05 AM
Business Wire

Blood-based test enables identification of patients eligible for targeted treatment with VEPPANU™

Approval marks Guardant’s third ESR1 companion diagnostic FDA approval to help guide timely treatment decisions for patients with advanced breast cancer

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the Guardant360® CDx liquid biopsy test as a companion diagnostic for VEPPANU (vepdegestrant). VEPPANU, jointly developed by Arvinas, Inc. and Pfizer Inc., is approved for the treatment of adults with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

The approval of Guardant360 CDx enables a non-invasive, blood-based method to identify patients with ESR1 mutations who may be eligible for treatment with VEPPANU. ESR1 mutations are a known mechanism of resistance to endocrine therapy and are commonly observed in patients with advanced disease.

“This latest FDA approval using Guardant360 CDx reflects where cancer care is headed using blood-based testing to detect resistance earlier and guide smarter treatment decisions,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “By identifying ESR1 mutations with just a simple blood draw, we’re helping bring more precise, personalized options to patients when they need them most.”

Vepdegestrant, discovered by Arvinas and co-developed with Pfizer, is a PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader therapy. It is designed to selectively degrade the estrogen receptor, offering a targeted treatment option for patients whose cancers are driven by ESR1 mutations. The approval is supported by clinical data demonstrating the clinical utility of identifying ESR1 mutations to guide treatment selection in ER+/HER2- advanced breast cancer.

This latest FDA approval for Guardant360 CDx marks the third ESR1 companion diagnostic approval. It is the 26th companion diagnostic indication across multiple tumor types, building on the platform’s increasing clinical utility and broad coverage by Medicare and commercial payers, representing more than 300 million covered lives.

About Guardant360® CDx

Guardant360 CDx is the first FDA-approved liquid biopsy for comprehensive genomic profiling. It detects multiple genomic alterations across all solid tumors and is approved as a companion diagnostic for therapies in non-small cell lung cancer, breast cancer, and colorectal cancer. For more information, visit Guardant360 CDx.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260504905593/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health Receives FDA Approval for Guardant360® CDx as a Companion Diagnostic for Arvinas and Pfizer’s VEPPANU (vepdegestrant) for Patients with ER+/HER2- Advanced Breast Cancer with ESR1 Mutations

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US Market News 2月前

Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ PlatformApril 30, 2026 8:05 AM
Business Wire

Multi-year global collaboration will leverage Guardant’s tissue and liquid biopsy portfolio to support clinical development and companion diagnostic strategies

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a multi-year strategic collaboration with Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, to support the development and potential commercialization of Nuvalent’s oncology pipeline using the tissue and liquid offerings of the Guardant Infinity™ platform.

The collaboration reflects the growing importance of precision diagnostics in oncology drug development, where biomarker-driven approaches are increasingly essential for identifying appropriate patient populations, improving trial efficiency, and supporting regulatory approvals.

As key components of the collaboration, Guardant Health and Nuvalent plan to:

Utilize Guardant’s portfolio of tissue and liquid biopsy tests to support certain Nuvalent global clinical studies;

Evaluate opportunities to develop Guardant tissue and/or liquid biopsy assays as companion diagnostics (CDx) to support potential regulatory approvals of Nuvalent’s current investigational candidates; and,

Collaborate on the global commercialization of Nuvalent’s product candidates, if approved, and Guardant companion diagnostics across major global key markets.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

About Nuvalent

Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, and the potential of Nuvalent’s pipeline programs, including potential regulatory approvals and commercialization of its product candidates, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s or Nuvalent’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in their respective Annual Reports on Form 10-K for the year ended December 31, 2025, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health and Nuvalent as of the date hereof, and Guardant Health and Nuvalent disclaim any obligation to update any forward-looking statements provided to reflect any change in their expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260430014027/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health Announces Multi-Year Strategic Collaboration with Nuvalent to Develop Companion Diagnostics and Support Potential Commercialization of Targeted Cancer Therapies Using the Guardant Infinity™ Platform

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US Market News 3月前

Guardant Health to Report First Quarter 2026 Financial Results on May 7, 2026April 16, 2026 4:05 PM
Business Wire
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will report financial results for the first quarter 2026 after market close on Thursday, May 7, 2026. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

Live audio of the webcast will be available on the “Investors” section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Source: Guardant Health, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260416881767/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health to Report First Quarter 2026 Financial Results on May 7, 2026

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iHub News 3月前

Guardant Health real-world data supports Japan approval of ENHERTU for HER2-positive tumorsMarch 30, 2026 10:29 AM
IH Market News
Guardant Health, Inc. (NASDAQ:GH) said real-world evidence generated through its InfinityAI platform helped support the recent approval of ENHERTU® (trastuzumab deruxtecan) in Japan for patients with previously treated HER2-positive metastatic solid tumors.Japan’s Ministry of Health, Labour and Welfare (MHLW) granted the approval for ENHERTU, which is developed and commercialized by Daiichi Sankyo (TSE:4568), for patients with advanced or recurrent HER2-positive cancers — defined as HER2 (ERBB2) gene amplification or immunohistochemistry (IHC) 3+ — who are refractory or intolerant to standard treatments.The regulatory decision was supported by results from multiple clinical trials, including HERALD, DESTINY-PanTumor02, DESTINY-CRC02 and DESTINY-Lung01, along with supplemental real-world evidence generated using InfinityAI, Guardant Health’s artificial intelligence platform for analyzing clinical and molecular datasets.HER2 amplification is well established in breast cancer, but identifying eligible patients and building evidence in other tumor types remains challenging, particularly in biomarker-defined populations with relatively low prevalence. In these settings, real-world data can help identify patients at scale and better characterize unmet medical need.For the Japanese regulatory submission, Daiichi Sankyo incorporated real-world evidence derived from InfinityAI alongside clinical trial results. Guardant Health and Daiichi Sankyo jointly analyzed outcomes from a large cohort of patients whose HER2 amplifications were identified using Guardant360®, showing significant unmet need and real-world clinical relevance across multiple tumor types.The collaboration demonstrates how large-scale real-world evidence can complement traditional clinical trial data, particularly in genomic subpopulations where enrolling sufficient patients into trials can be difficult.“This approval highlights the growing role of real-world evidence in precision oncology and underscores the potential for new regulatory pathways in rare biomarker-defined populations,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “InfinityAI allows us to generate clinically meaningful evidence from large-scale, longitudinal data, helping to complement traditional trials and ultimately expand access to targeted therapies for patients who might otherwise be overlooked.”About InfinityAIInfinityAI is Guardant Health’s artificial intelligence and machine learning platform designed to generate real-world evidence and data-driven insights. The platform is built on a large proprietary dataset derived from Guardant Health’s clinical testing portfolio and integrates longitudinal, multimodal molecular and clinical information, including genomic and epigenomic data, into a unified framework.InfinityAI supports pharmaceutical and healthcare partners across research, drug development and clinical applications such as biomarker discovery, patient identification and clinical trial optimization. Its analytics tools are designed to enable more informed decision-making and improve both development efficiency and patient outcomes.More about Guardant HealthGuardant Health is a precision oncology company focused on improving cancer detection and treatment through advanced diagnostics and data analytics. Founded in 2012, the company develops blood and tissue-based tests, real-world data platforms and AI-driven insights designed to help identify cancer earlier, monitor recurrence and guide treatment decisions for patients with advanced disease.Guardant Health stock price

Original: Guardant Health real-world data supports Japan approval of ENHERTU for HER2-positive tumors

Verana Health and Guardant Health Partner to Advance Precision Medicine with Real-World DataMarch 24, 2026 9:15 AM
PR Newswire (US)

Combination of high quality, variable-rich, curated EHR data with genomics enhances understanding of the patient journey and aids in therapy development SAN FRANCISCO, March 24, 2026 /PRNewswire/ -- Verana Health®, a digital health company dedicated to revolutionizing patient care and clinical research through real-world data (RWD), has announced a new partnership with leading precision oncology company Guardant Health Inc. (Nasdaq: GH) that will allow biopharmaceutical researchers to access the combined resources of Verana's regulatory-grade, therapeutic-specific EHR curated datasets from leading medical societies and academic and community medical centers and Guardant's clinicogenomic testing data to accelerate the development of new therapies and enhance on-going patient care.

Using the extensive datasets the collaboration provides, research scientists can more easily understand and further validate correlations between molecular biomarkers, treatment decisions and clinical outcomes. For example, from an urology perspective novel use cases of combining genomics data with NMIBC EHR curated data could enhance understanding the patient journey in risk refinement beyond stage/grade, lead to better treatment selection insights (i.e., who benefits from Bacillus Calmette-Guerin (BCG), the standard of care for most Non-muscle invasive bladder cancer (NMIBC) patients vs. who needs earlier escalation, and validate biomarker measures (e.g., Tumor Mutational Burden (TMB)) using real-world response and outcome endpoints. Ultimately, the combination provides greater insights into existing research data with comprehensive real-world data—including critical longitudinal serial testing information—needed to optimize drug development and accelerate programs that treat cancer across diverse patient populations."Clinicogenomic data empowers research scientists to test hypotheses by studying patient genomic profiles and real-world outcomes to guide the development of targeted therapies that can be used to personalize treatment for each cancer patient," said Sujay Jadhav, CEO of Verana Health. "Connecting Guardant's data to Verana Health's in-depth, real-world oncology, and urology data assets will also allow researchers to anticipate treatment responses and accelerate drug development for existing and new population segments.""The real-world data partnership with Verana marks another significant milestone in our mission to advance novel therapies, in particular cancer, with data," said Craig Eagle, MD, Guardant Health chief medical officer. "Giving biopharmaceutical researchers the ability to connect detailed information about tumor biology and therapy response with real-world patient outcome data will expedite the discovery of new biomarker-based therapies for patients and make the drug development process more economical as well."Guardant's extensive real-world longitudinal serial testing datasets span all stages of the disease, from initial tumor profiling for therapy selection to recurrence and therapy response monitoring, while Verana Health's highly curated data tracks a patient's complete cancer care journey, drawing from both academic and community care center settings. This new collaboration with Guardant deepens Verana Health's data by expanding its breadth into solid tumors, particularly lung, breast, and colorectal cancers, creating a broader, more diverse data set with considerable patient overlap for enhanced clinical insights.The recent merger of COTA with Verana Health has expanded the therapeutic footprint. With its focus on real-world patient data in oncology, COTA complements Verana Health data and technology offerings across ophthalmology, urology, and neurology. The company is an exclusive partner of the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) and the American Urological Association (AUA) Quality (AQUA)® Registry. The combined portfolio supports life sciences companies with clinical trials, drug submissions, health economics research, market-access strategies, and clinicians with MIPS advisory services.The merger strengthens Verana Health's relationships within the biopharma industry. The combined company will serve 17 of the top 20 global biopharma companies, with access to over 95 million patients, over 20,000 contributing clinicians, including expanded network access to more than 30 Academic Medical Centers, increasing accessible oncology patients to over 10 million.Additionally, the companies' combined regulatory expertise positions them as a top-tier partner for organizations working closely with the FDA. Together, the joint entity represents a powerhouse of RWD offerings and clinical trial solutions for accelerating results in the life sciences industry.Join us on an upcoming webinar Precision Oncology Has a Blind Spot—and It's Not Genomics on Tuesday, April 14 to learn more. Register now.Researchers interested in more information can schedule a time to meet Verana Health representatives during the American Urological Association (AUA) 2026 Annual Meeting (Booth 2469) or post-event.About Verana HealthVerana Health, Inc.® is a digital health company revolutionizing patient care and clinical research by utilizing physician expertise and artificial intelligence to unlock the true potential of real-world data. With exclusive access to the world's largest patient data sources in oncology, ophthalmology, neurology, and urology. Verana Health is powering real-world evidence generation. Clinicians utilize these insights to improve the quality of care and quality of life for patients, and life sciences companies rely on the insights to accelerate the development of new therapies. For more information, visit www.veranahealth.com.

View original content to download multimedia:https://www.prnewswire.com/news-releases/verana-health-and-guardant-health-partner-to-advance-precision-medicine-with-real-world-data-302719285.htmlSOURCE Verana Health

Original: Verana Health and Guardant Health Partner to Advance Precision Medicine with Real-World Data

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US Market News 4月前

Guardant Health to Present 28 Abstracts Highlighting Advances in Tumor Typing, Therapy Selection and Expanded Utility of Multiomic Tissue and Liquid Biopsy Testing at AACR 2026March 18, 2026 8:05 AM
Business Wire

Guardant Reveal demonstrates expanded utility in identifying new, primary cancers during minimal residual disease (MRD) monitoring

Studies show strong performance of Guardant360 Tissue in determining tissue of origin in diagnostically challenging settings

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present 28 abstracts, including 3 oral sessions, showcasing advances in methylation-based tumor classification and liquid biopsy technology at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California taking place April 17 - 22, 2026.

Key data that will be presented include:

An oral presentation of research data showing high accuracy of Guardant360 Tissue in determining tissue of origin with strong performance in cancers of unknown primary, correctly identifying the likely origin in approximately 92% of known cases across more than 6,000 tissue samples and 24 tumor types and supporting the clinical utility of methylation-based tumor typing for tissue samples in diagnostically challenging settings.

An oral presentation showcasing the expanded utility of Guardant360 Liquid beyond basic genomic testing, highlighting the strength of its novel epigenomic features in increasing clinical actionability. Researchers found that Guardant360 Liquid demonstrated actionable findings for 85% of metastatic breast cancer patients and 89% of patients with advanced colorectal cancer.

A real-world analysis evaluating the utility of Guardant Reveal to identify new primary malignancies during minimal residual disease (MRD) monitoring, demonstrating the potential to detect separate primary cancers in patients over time with non-invasive, liquid biopsy technology.

Additional research bolstering the potential of Guardant360 Tissue in expanding access to targeted treatment options showing that a tissue-based genomic instability score (GIS) can accurately detect DNA repair deficiencies in breast, ovarian, and pancreatic cancers and accurately identifying patients who may benefit from PARP inhibitors.

“The breadth of the data Guardant will be presenting demonstrate the power of our blood- and tissue-based tests in helping address critical gaps across cancer care,” said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. “From identifying cancers of unknown primary and detecting new malignancies in tandem with MRD monitoring to expanding treatment options for more cancers, we are eager to present these findings along with our research collaborators at the AACR meeting and proud to offer innovative tests that are meeting today’s most complex challenges in cancer care.”

Key Guardant Health and collaborator presentations at AACR 2026

Presentation

Title

Time / Location

Monday, April 19

1316

A methylation-based molecular tumor typing classifier for tissue samples from cancers of unknown primary

April 19, 2026 / 3:00 PM - 5:00 PM PT

Tuesday, April 20

4016

Tissue-based homologous recombination deficiency status prediction in patients with breast, ovarian, and pancreatic cancers

April 20, 2026 / 2:30 PM - 4:30 PM PT

2279

DNA methylation-based classifier predicts SERD benefit in ESR1 wild-type HR+/HER2- breast cancer

April 20, 2026 / 9:00 AM - 12:00 PM PT

Poster hall / Section 34

Wednesday, April 21

6512

Exploring clinical actionability of expanded liquid biopsy in advanced breast and colorectal cancers

April 21, 2026 / 2:00 PM - 5:00 PM PT

Poster Section 43

6512

Evaluating molecular tumor type predictions for identifying new primary malignancies - A real-world clinical genomics analysis

April 21, 2026 / 2:00 PM - 5:00 PM PT

Poster Section 43

CT230

STRIDE regimen of tremelimumab and durvalumab as non-operative management strategy of MSI-H resectable gastric or gastroesophageal junction adenocarcinoma (GAC/GEJAC): final results of the cohort 2 of INFINITY study by GONO GI

April 21, 2026 / 10:15 AM – 12:15 PM PT

The full abstracts for Guardant Health and a list of all abstracts being presented at the AACR Annual Meeting can be found here.

About Guardant360

Guardant360 Liquid is a blood-based test that analyzes tumor DNA fragments circulating in the blood (cfDNA) to identify genetic mutations in advanced solid tumors, helping oncologists find targeted therapies. It offers an alternative to tissue biopsies, providing comprehensive genomic profiling (CGP) to guide personalized treatment for a wide range of solid cancers including lung, breast, colorectal, and prostate cancer. Guardant360 Liquid is guideline-complete across all advanced solid tumors, and has been clinically validated in more than 1,500 publications and research abstracts.

About Guardant Reveal

Guardant Reveal is a tissue-free liquid biopsy test that detects minimal residual disease (MRD) and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights.

The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260318529389/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health to Present 28 Abstracts Highlighting Advances in Tumor Typing, Therapy Selection and Expanded Utility of Multiomic Tissue and Liquid Biopsy Testing at AACR 2026

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US Market News 4月前

Guardant Health Launches Shield Multi-Cancer Detection (MCD) Test in Multiple Markets in Asia with Manulife PartnershipMarch 16, 2026 8:05 AM
Business Wire

Partnership marks the first introduction of Shield™ multi-cancer detection test in the region with availability across Hong Kong, Singapore and the Philippines

Eligible Manulife customers in Hong Kong, Singapore and the Philippines will gain access to the Shield MCD test beginning in April 2026

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the launch of the Shield™ multi-cancer detection (MCD) laboratory developed test (LDT) in multiple markets in Asia. The Shield MCD test is a methylation-based blood test for the detection of multiple cancer types including bladder, colorectal, breast, prostate, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

The partnership with Manulife marks a first-of-its kind collaboration with a major insurer in Asia to expand access to early cancer detection in the region by offering innovative technologies like Guardant’s Shield MCD test to address real, unmet health needs. As part of the partnership, eligible Manulife customers in Hong Kong, Singapore and the Philippines will gain access to the Shield MCD test beginning in April 2026. Manulife is a large insurer in Asia serving customers across life, health, retirement and other wealth products and services.

“The introduction of our Shield MCD test in Asia marks a critical milestone in our mission to transform early detection and expand commercial access globally,” said AmirAli Talasaz, Guardant Health co-CEO. “We built our Shield technology from the ground-up nearly 10 years ago with a vision to address the most common cancers where early detection is a critical component to survivorship. Shield MCD has the potential to significantly increase screening participation in Asia with the promise of detecting multiple cancers at an early stage with just a blood draw.”

Cancer remains one of the leading causes of death in Asia. With just a blood draw, the Shield MCD test screens for 10 of the most common cancers, many of which carry high mortality rates in the region.

“By being the first insurer in Asia to offer the Shield MCD test, we’re empowering our customers with a credible and valued service that encourages proactive health management,” said Steve Finch, President and CEO of Manulife Asia. “This exclusive partnership demonstrates our commitment to offering innovative and differentiated solutions to improve the health outcomes of our customers.”

In the United States, the Shield MCD test has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) based on its strong performance in predicting the presence of cancers and cancer tissue of origin in the National Cancer Institute (NCI) Vanguard Study evaluating emerging MCD technology.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

About Manulife

Manulife Financial Corporation is a leading international financial services provider, headquartered in Toronto, Canada. Anchored in our ambition to be the number one choice for customers, we operate as Manulife across Canada and Asia, and primarily as John Hancock in the United States, providing financial advice, insurance and health solutions for individuals, groups and businesses. Through Manulife Wealth & Asset Management, we offer global investment solutions, financial advice, and retirement plan services to individuals, institutions, and retirement plan members worldwide. At the end of 2025, we had more than 37,000 employees, over 106,000 agents, and thousands of distribution partners, serving over 37 million customers with operations across 25 markets globally. We trade as ‘MFC’ on the Toronto, New York, and Philippine stock exchanges, and under ‘945’ on the Hong Kong stock exchange. Not all offerings are available in all jurisdictions. For additional information, please visit manulife.com.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260316025112/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com
Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health Launches Shield Multi-Cancer Detection (MCD) Test in Multiple Markets in Asia with Manulife Partnership

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US Market News 4月前

New Guardant Health/Harris Poll Survey Shows 92% of All Eligible Americans Believe Colorectal Cancer Blood Tests Should be Accessible and Covered Similar to MedicareMarch 13, 2026 8:05 AM
Business Wire

Survey highlights barriers to colorectal cancer screening for adults 45 and over

Overwhelming majority (92%) of Americans ages 45 and over believe blood-based screening should be covered with no co-pay

Shield™ by Guardant is proven to increase screening rates with a 93% adherence rate by offering a quick, easy option to screen with just a blood draw

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the results of a new national survey conducted on its behalf by The Harris Poll with findings demonstrating that more than 9 out of 10 Americans ages 45 and over believe in ensuring broader coverage for blood-based colorectal cancer (CRC) screening, including new innovations like Shield™ by Guardant, a methylation partitioning cell-free DNA (mp-cfDNA) test and the first and only FDA-approved blood test for primary colorectal cancer screening.

The survey showed an overwhelming majority of Americans of screening-eligible age (92%) believe that blood-based colorectal cancer screening should be covered with no co-pay similar to Medicare Part B and VA Community Care coverage. National CRC screening guidelines from the United States Preventive Services Task Force (USPSTF) were last updated in 2021 lowering the recommended screening age from 50 to 45 for average risk individuals, but have yet to be updated to include a new innovative screening option approved by the FDA in 2024.

Poll findings also highlighted the likely barriers to colorectal cancer screening, including colonoscopies and stool-based tests, as millions of Americans ages 45 and over remain unscreened.

A majority (71%) have felt/would feel anxious before having a colonoscopy

Over three-quarters of screening-eligible Americans (77%) said they would be less likely to avoid or delay a colorectal cancer screening knowing that there is an FDA-approved blood test option available

85% of screening-eligible Americans said they would be more likely to get a colonoscopy if they had a positive result on a blood-based colorectal cancer screening test first

Over half (54%) say stool-based tests “gross them out,” and nearly two in five (38%) say they would have a hard time completing one

“This year’s survey conducted by The Harris Poll gives insight into the barriers that drive millions of Americans to avoid their recommended colorectal screening and the overwhelming support in expanding access to the latest innovation in colorectal cancer screening to close our nation’s screening gap,” said Dr. Craig Eagle, M.D. Guardant Health chief medical officer. “Preventive care should be accessible to everyone. Guardant’s Shield blood test is a critical avenue in getting more patients screened by providing a quick, easy option to screen for colorectal cancer with just a blood draw, helping to detect cancer early, when it’s more treatable.”

Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. with a 91 percent five-year survival rate if caught in early stages.1 Shield is proven to increase screening rates in the real world, with 93% of patients completing the test in the first 100,000 Shield tests ordered - a significant improvement in screening adherence rates over other types of tests.2

Recently, the National Comprehensive Cancer Network included the Shield blood test in its updated CRC screening guidelines, paving the way for improved patient access and additional major clinical guideline inclusions. Shield is covered by Medicare, Veterans Affairs Community Care Network and TRICARE, and is commercially available across the U.S.

The Harris Poll conducted the survey on behalf of Guardant Health from February 24-26, 2026, among 1,189 U.S. adults aged 45 and older. Data was weighted where necessary to reflect the U.S. population. The sampling precision of Harris online polls is measured using a Bayesian credible interval. For this study, the sample data are accurate to within ± 3.6 percentage points using a 95% confidence level.

For complete survey methodology, including weighting variables and subgroup sample sizes, please contact Meaghan Smith at Guardant Health.

About Shield

Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

About The Harris Poll

The Harris Poll is a global consulting and market research firm that strives to reveal the authentic values of modern society to inspire leaders to create a better tomorrow. It works with clients in three primary areas: building twenty-first-century corporate reputation, crafting brand strategy and performance tracking, and earning organic media through public relations research. One of the longest-running surveys in the U.S., The Harris Poll has tracked public opinion, motivations, and social sentiment since 1963, and is now part of Stagwell, the challenger holding company built to transform marketing.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

____________________

1

American Cancer Society. Mortality Under 50 Declines for 4 of 5 Leading Cancers in U.S., but Colorectal Now Top Cancer Killer, New ACS Study Finds. American Cancer Society Pressroom. January 22, 2026. https://pressroom.cancer.org/under-50-mortality-declines

2

Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260313848518/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com
Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: New Guardant Health/Harris Poll Survey Shows 92% of All Eligible Americans Believe Colorectal Cancer Blood Tests Should be Accessible and Covered Similar to Medicare

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US Market News 4月前

Guardant Health’s Shield Blood-based Screening Test for Colorectal Cancer Now Accessible Through National Test Ordering and Collection Network of Quest DiagnosticsMarch 10, 2026 8:05 AM
Business Wire

Strategic collaboration to enable streamlined and accelerated access to Shield blood-based colorectal cancer screening test across Quest’s vast network

Physicians nationwide now have the ability to order Shield

Shield is proven to increase screening rates with a 93% screening adherence rate

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the Shield™ by Guardant blood-based screening test is now widely accessible for physician order through the nationwide connectivity of Quest Diagnostics, equipping clinicians with access to blood-based screening innovation for colorectal cancer (CRC) through one of the largest diagnostic ecosystems in the United States.

Shield is the first and only blood test to receive full FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. Under the agreement, providers that order lab testing from Quest can now directly access Shield through their existing Quest account and electronic health record (EHR).

Quest provides healthcare connectivity solutions to nearly 650,000 clinician and hospital accounts annually in the United States. Providers can also utilize Quest’s approximately 2,000 patient service centers and approximately 6,000 in-office phlebotomists across the United States for blood draws for Shield.

“Activating our strategic collaboration with Quest marks a pivotal milestone in broadening access to Shield and empowering primary care physicians across the country to bring the lifesaving advantages of early detection to their patients with just a blood draw,” said AmirAli Talasaz, Guardant Health co-CEO. “Shield’s innovative technology supported by Quest’s vast, nationwide infrastructure will strengthen our ability to fundamentally transform colorectal cancer screening by equipping doctors with a quick, easier screening option patients are far more likely to complete.”

As part of the strategic arrangement, Quest’s national commercial sales team will actively educate primary care physicians about access to the test.

Colorectal cancer is the second leading cause of cancer-related deaths in the U.S. with a 91 percent five-year survival rate if caught in early stages.1 Yet, over 54 million people do not complete the recommended screening, in part because they find the available options, colonoscopy and stool tests, unpleasant or inconvenient.2 With Shield, individuals can be screened with just a blood draw, helping to detect cancer early, when it is more treatable.

Shield is proven to increase screening rates in the real world, with 93% of patients completing the test in the first 100,000 Shield tests ordered – a significant improvement in screening adherence rates over other types of tests.3 Recently, the National Comprehensive Cancer Network included the Shield blood test in its updated CRC screening guidelines, paving the way for improved patient access and additional major clinical guideline inclusions.

Shield is covered by Medicare, Veterans Affairs Community Care Network and TRICARE, and is commercially available across the U.S.

About Shield

Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

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1

American Cancer Society. Mortality Under 50 Declines for 4 of 5 Leading Cancers in U.S., but Colorectal Now Top Cancer Killer, New ACS Study Finds. American Cancer Society Pressroom. January 22, 2026. https://pressroom.cancer.org/under-50-mortality-declines

2

Ebner DW, Kisiel JB, Fendrick AM, Estes C, Li K, Vahdat V, Limburg PJ. Estimated average-risk colorectal cancer screening-eligible population in the US. JAMA Netw Open. 2024 Mar 29;7(3):e245537. doi:10.1001/jamanetworkopen.2024.5537. PMID: 38551567; PMCID: PMC10980958

3

Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260310124738/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com
Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health’s Shield Blood-based Screening Test for Colorectal Cancer Now Accessible Through National Test Ordering and Collection Network of Quest Diagnostics

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US Market News 4月前

Guardant Health Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)February 27, 2026 4:05 PM
Business Wire
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that on February 23, 2026, the Compensation Committee of Guardant’s Board of Directors approved the granting of restricted stock units (“RSUs”) representing 41,852 shares of its common stock to 88 new non-executive employees and one non-qualified stock option award to purchase 4,965 shares of its common stock to one new non-executive employee with a grant date of February 23, 2026 under the Guardant Health, Inc. 2023 Employment Inducement Incentive Award Plan (the “Inducement Plan”). The RSUs and stock options were granted as inducements material to the employees entering into employment with Guardant in accordance with Nasdaq Listing Rule 5635(c)(4).

The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Guardant, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Guardant, pursuant to Nasdaq Listing Rule 5635(c)(4).

One-third of the shares underlying each RSU award vest on an annual basis on the anniversary of the vesting commencement date, subject to each employee’s continued employment with Guardant as of each such vesting date. The RSUs are subject to the terms and conditions of the Inducement Plan and the terms and conditions of a RSU award agreement covering the grant.

All stock options have an exercise price of $94.42 per share, which is equal to the closing price of Guardant’s common stock on The Nasdaq Global Select Market on February 23, 2026. One-third of the shares underlying each stock option award vest on the one-year anniversary of the vesting commencement date and continue to vest monthly thereafter over 24 months, subject to each employee’s continued employment with Guardant as of each such vesting date. The stock options are subject to the terms and conditions of the Inducement Plan and the terms and conditions of a stock option award agreement covering the grant.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260227837288/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

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US Market News 5月前

Guardant Health Launches Community Colorectal Cancer Screening Grant Program in Recognition of CRC Awareness Month, Applications Now OpenFebruary 12, 2026 2:35 PM
PR Newswire (US)

Patient and Public Health Groups Invited to Apply for Up to 100 Shield Colorectal Cancer Blood Tests to Support Community Screening Events and Educational Outreach in MarchPALO ALTO, Calif., Feb. 12, 2026 /PRNewswire/ -- Ahead of Colorectal Cancer (CRC) Awareness Month in March, Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the launch of its Community Colorectal Cancer Screening Grant Program, designed to support community-led efforts to expand access to colorectal cancer screening throughout March.As part of the grant program, Guardant Health will provide selected patient advocacy, non-profit, public health and health-adjacent organizations with up to 100 Shield tests per organization to support efforts to increase screening participation, including community health fairs, screening events and awareness month programming and educational outreach. All Shield tests will be provided at no cost to the patient or participating organization.Shield is the first and only blood test approved by the FDA as a primary screening option for CRC for adults age 45 and older at average risk, offering patients a more pleasant and convenient option for screening by overcoming barriers associated with other screening methods.Colorectal cancer is the leading cause of cancer-related deaths nationwide, yet it is highly preventable through recommended screening. Guardant's grant program reflects the company's commitment to removing barriers to screening – particularly in underserved and underscreened communities – and supporting community partners who are on the front lines of improving access to screening. Organizations with strong community and health outreach are encouraged to apply. Groups interested in participating should review the Request for Proposals (RFP) and complete the application form available here. Applications are due by February 17, 2026 (midnight PST), and approval notifications will be sent via e-mail on February 20, 2026.For questions about the application process, contact ShieldGrants@guardanthealth.com.About Shield
Shield is a methylation partitioning cell-free?DNA?(mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.Guardant Health Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health's liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health's financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operation" and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health's views as of any date subsequent to the date of this press release.

View original content:https://www.prnewswire.com/news-releases/guardant-health-launches-community-colorectal-cancer-screening-grant-program-in-recognition-of-crc-awareness-month-applications-now-open-302686809.htmlSOURCE Guardant Health, Inc.

Original: Guardant Health Launches Community Colorectal Cancer Screening Grant Program in Recognition of CRC Awareness Month, Applications Now Open

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US Market News 5月前

Largest Published Study of Molecular Residual Disease (MRD) in Stage III Colon Cancer Shows Guardant Reveal Blood Test More Precisely Identifies Risk of Recurrence After Surgery to Support Timely Treatment DecisionsFebruary 2, 2026 8:05 AM
Business Wire

Data published in Journal of Clinical Oncology supports routine use of circulating tumor DNA (ctDNA) testing in management of stage III colon cancer patients

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company and research collaborators at Mayo Clinic and the Alliance for Clinical Trials in Oncology today announced publication of the largest study to date evaluating circulating tumor DNA (ctDNA) for MRD detection in patients with resected stage III colon cancer after surgery and before adjuvant chemotherapy. Results of the study, published in the Journal of Clinical Oncology, show that detecting ctDNA with the Guardant Reveal® blood test better predicts recurrence and overall survival than standard staging.

Researchers found that about 20 percent of patients in the phase III trial, which was presented at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting, involving more than 2,000 patients still had detectable ctDNA in their blood after surgery. Guardant Reveal identified patients at a four-to-six-fold higher rate of disease recurrence or reduced survival. Even patients with smaller tumors or fewer affected lymph nodes found as part of traditional staging had an over 6-fold higher rate of events if ctDNA was detected. The findings support the integration of tissue-free ctDNA testing into routine postoperative management to better identify patients at high risk of recurrence who may benefit from intensified surveillance or alternative adjuvant strategies.

Measuring the amount of cancer DNA in the blood, a marker known as tumor fraction, further distinguished those at the highest risk of early recurrence and worse survival. This additional layer of information may help clinicians prioritize patients who need the most intensive surveillance or consideration of alternative therapies.

“The data suggest that not only the presence of ctDNA, but the amount of ctDNA, as identified by Guardant Reveal may help refine risk beyond standard TNM staging, and could be used to guide adjuvant treatment and surveillance decisions,” said Frank Sinicrope, MD, professor of oncology and medicine at Mayo Clinic and principal investigator for the study. “ctDNA testing after surgery improves the accuracy of estimating a patient’s risk of cancer recurrence, enabling more tailored recommendations for adjuvant chemotherapy and follow-up monitoring. It also identifies high risk patients who are likely to recur despite standard treatment, and who may benefit from alternative therapeutic approaches.”

“This large study adds to growing evidence that ctDNA testing with Guardant Reveal after surgery helps answer the question patients care about most: Am I really cancer-free?” said Dr. Craig Eagle, Guardant Health Chief Medical Officer. “Personalizing care after surgery is essential as clinicians and patients decide what comes next. Guardant Reveal fits easily into routine practice and provides timely, actionable insight—helping identify patients at high risk while sparing others unnecessary treatment and anxiety.”

Today’s announcement is the latest data reinforcing the clinical utility of Guardant Reveal in molecular residual disease and beyond. Guardant recently expanded Reveal to support late-stage therapy response monitoring, enabling ctDNA-based assessment of treatment effectiveness across solid tumors. This adds to evidence from early-stage breast cancer publications that Reveal’s tissue-free approach can identify patients at elevated risk of recurrence and support more personalized care.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

About Mayo Clinic

Mayo Clinic is a nonprofit organization committed to innovation in clinical practice, education and research, and providing compassion, expertise and answers to everyone who needs healing. Visit the Mayo Clinic News Network for additional Mayo Clinic news.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2024 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260202593149/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com
Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Largest Published Study of Molecular Residual Disease (MRD) in Stage III Colon Cancer Shows Guardant Reveal Blood Test More Precisely Identifies Risk of Recurrence After Surgery to Support Timely Treatment Decisions

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US Market News 5月前

Guardant Health to Report Fourth Quarter and Full Year 2025 Financial Results on February 19, 2026January 29, 2026 4:05 PM
Business Wire
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will report financial results for the fourth quarter and full year 2025 after market close on Thursday, February 19, 2026. Company management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

Live audio of the webcast will be available on the “Investors” section of the company website at: www.guardanthealth.com. The webcast will be archived and available for replay after the event.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Source: Guardant Health, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260129040273/en/
Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Meaghan Smith

press@guardanthealth.com

Original: Guardant Health to Report Fourth Quarter and Full Year 2025 Financial Results on February 19, 2026

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ranchhand71 7月前

Rollout of a dozen new tests over next 6 months will leverage the increased salesforce expense. Stock upside to over $125 by June. Morgan Stanley saying $130 in new report .

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ranchhand71 8月前

With Break even at the corporate level on the horizon a year earlier than current consensus could take us to $130 in next 12 months

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ranchhand71 11月前

This quarter off to gang busters start with new crypto and bitcoin focused accounts benefit big from huge interest. Most shareholder and SOFI analysts do not know about the SOFI Hong Kong offices . Doing very well !!!

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ranchhand71 1年前

Have them check the walls for mold !!!

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BottomBounce 1年前

At Newton-Wellesley Hospital in Massachusetts, a startling cluster of brain tumor diagnoses has emerged among vaccinated nurses on the fifth-floor maternal care ward. Ten longtime staff members have been affected simultaneously, sparking alarm and raising questions about a… pic.twitter.com/ADHAwQWjVN— “Sudden And Unexpected” (@toobaffled) March 30, 2025 $GH

New to the board. Evaluating whether to invest in Guardant Health or Exact Sciences.

After speaking with multiple gastroenterologists and family physicians, a clear consensus emerged: Cologuard Plus (Exact Sciences) is widely regarded as the more accurate test. In contrast, Shield (Guardant Health) is viewed as having a very limited clinical role—primarily for patients who refuse both colonoscopy and stool-based tests, a scenario described as rare in routine practice.

From an investment perspective, it's important to note that many providers consider Shield to fall below the standard of care due to its lower diagnostic accuracy. Several physicians mentioned the increased liability risk and emphasized that offering Shield requires significantly more documentation and patient counseling. Physicians must clearly outline its inferior performance compared to colonoscopy and stool-based testing, and thoroughly document that discussion to protect against potential malpractice exposure.

This added complexity—combined with Shield’s limited clinical niche—could pose serious barriers to widespread adoption, and is a critical factor for investors to weigh when considering the long-term viability of Guardant’s screening platform.

I am interested in your perspectives

GH that awful Cathie has been a recent buyer

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x993231 2年前

I'm in, $33 ish I like the potential. Short wise only 6% of float and 6 million shares only 200 million so I don't think we'll see a squeeze like ASTS has been doing.

X. I just like to throw down a marker when I invest, I'm a long as in 80% of the time I hold shares for years and years many for decades.

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Monksdream 2年前

The American biotechnology company Guardant Health, which produces liquid biopsy tests to detect cancer from mutations and other modifications in blood samples,[1] was co-founded by Helmy Eltoukhy and AmirAli Talasaz during 2012–2013.[2][3] According to John Dorfman of the Pittsburgh Tribune-Review, Talasaz and Eltoukhy discovered a technique which "involves detecting and monitoring tumor fragments circulating in the patient's bloodstream", as an alternative to traditional tissue biopsies.[4] The duo met at Stanford University in 2002 and worked together at Illumina, until Talasaz left in 2012.[5]

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SubPenny0001 2年前

I would add GH with EXAS both would score on the final outcome. FDA is expected to decide whether to approve Shield later this year.

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Trooperstocks 2年前

For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. $GH

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Trooperstocks 2年前

$GH -Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.

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Trooperstocks 2年前

Guardant Health unveiled initial results from the ECLIPSE study validating the performance of the Shield test at the 2023 DDW meeting. The data served as the basis for Guardant Health’s submission of a premarket approval (PMA) application to the FDA, and the full study results have since been published in the March 2024 issue of The New England Journal of Medicine. An FDA Advisory Panel is scheduled to review the PMA application on May 23.

The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting will be available at the DDW website.

For information and updates from the meeting, follow Guardant Health on LinkedIn, X (Twitter) and Facebook. $GH

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Trooperstocks 2年前

$GH Guardant Health Inc NASDAQ -Guardant Health to present real-world data supporting performance of Shield™ blood test for colorectal cancer screening at 2024 Digestive Disease Week
May 16 2024 - 8:05AM

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will present data from two real-world studies at the 2024 Digestive Disease Week (DDW) meeting in Washington, DC, highlighting the value of the company’s Shield™ test in colorectal cancer (CRC) screening.

“One in three eligible American adults have not been screened for CRC, in part because the currently available methods are unpleasant or inconvenient,” said AmirAli Talasaz, co-CEO of Guardant Health. “The data we will share at DDW underscores the important role that our Shield blood test can have in both improving screening rates and in detecting more colorectal cancer at an early stage, when it is most treatable. We look forward to sharing this important data at DDW.”

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DewDiligence 4年前

GH—(-34%/AH)—reports_results_of “Shield” ctDNA—(liquid biopsy)—diagnostic_for colorectal cancer:

https://finance.yahoo.com/news/guardant-health-announces-positive-results-211600504.html

https://finance.yahoo.com/news/1-guardant-dna-blood-test-220041937.html

GH’s data aren’t bad, but they aren’t as good as those for EXAS’s Cologuard, which is based on a stool sample rather than a blood sample.

EXAS is +24%/AH, adding about $2B(!) to its market cap.

In #msg-168735158 (from May 2022), I said: Although GH says Shield is as good as EXAS’ Cologuard and MYNZ’s ColoAlert, I find it hard to believe that a blood test can be as sensitive for CRC (and precancerous lesions) as a stool-based test.I stand by that.

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jerseyboy 5年前

I'm still feeling very good about owning this stock. There is no way I'll sell this before the next five years.

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jerseyboy 6年前

I like the nice, gradual, consistent rise in the share price. I think there is no way to lose money here, and I think the gains will be very substantial over the next two to three years.

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jerseyboy 6年前

So am I. This is THE company I have chosen in which to put my investment dollars that I feel is both a high-growth situation and one in which I am certain not to lose money.

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PR_12 6年前

2-3 years I'm thinking this is @ 3-5X current share price

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UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer Screening

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リアルタイムのディスカッションと取引のアイデア: 当社の強力なプラットフォームで自信を持って取引できます。

Guardant Health Inc (GH) ニュース

Form 4 - Statement of changes in beneficial ownership of securities

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Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

Form 4 - Statement of changes in beneficial ownership of securities

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UnitedHealth Group Now Covers Guardant Health’s Shield Blood Test for Colorectal Cancer Screening

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GH Discussion

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