- Largest national medical benefit manager in the U.S. expands coverage for FDA-approved Shield blood test for colorectal cancer (CRC) screening to eligible policyholders
- Increasing total covered Shield lives ages 45 and older to approximately 90 million, representing the vast majority of eligible patients in the U.S.
PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced its Shield™ blood test for colorectal cancer screening (CRC) will be covered in Carelon Healthcare Services clinical guidelines effective November 15. Carelon Healthcare Services is one of the largest specialty benefits managers in the country and subsidiary of one of the largest health insurance companies in the U.S spanning more than 14 states.
The new policy update from Carelon represents another meaningful expansion of commercial coverage in the U.S., driving total covered lives for Shield to approximately 90 million or 75% of all eligible patients for CRC screening.
Shield is the leading blood test for CRC screening detection as the first FDA-approved blood test for primary colorectal cancer screening in average-risk adults age 45 and older. Providing a more accessible screening option that overcomes the barriers associated with traditional methods, the Shield blood test provides Americans with the ability to screen for CRC with just a blood draw during a routine doctor’s visit.
The updated policy coverage from Carelon offers those above the age of 45 and at average risk of colorectal cancer access to the latest innovation in colorectal cancer screening, amid rising CRC rates for adults under 651 and mortality for younger adults as the leading cause of cancer death for those under 50.2
“With the largest major medical benefit manager in the U.S. to cover the Shield blood test for their members, approximately 90 million people nationwide now have access to Shield, bringing the most clinically-validated blood-based colorectal cancer screening option within reach for the vast majority of the eligible U.S. population,” said AmirAli Talasaz, Guardant Health co-CEO. “As we see colorectal cancer rates continue to rise for those under 65, including younger adults, access to Shield through Carelon marks another critical milestone in our commercial expansion and broader mission to make screening more accessible.”
Demonstrating the highest performance in CRC detection across all stages than published FIT performance, Shield is recommended in both American Cancer Society (ACS) 3 and National Comprehensive Cancer Network (NCCN) guidelines.4 With more than 200,000 tests performed in real-world settings, Shield is proven to significantly increase overall CRC screening completion for patients due for CRC screening across practice and health system settings, demonstrating over 90% screening adherence.5,6
Carelon provides medical benefit management to Blue Cross Blue Shield plans across 26 states, including Alabama, California, Colorado, Connecticut, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland/D.C., Massachusetts, Missouri, Montana, Nevada, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Oregon, Texas, Virginia, Washington and Wisconsin.
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. 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
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 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
4 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
5 Graham-Adderton C, Guerra CE, Ngo-Metzger Q, Hoang T, Raymond VM. Implementation of blood-based colorectal cancer screening: real-world adherence and outcomes. Curr Med Res Opin. 2025;41(10):1915-1920. doi:10.1080/03007995.2025.2582257
6 Coronado GD, Jenkins CL, Shuster E, et al. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. 2024;73(4):622-628. doi:10.1136/gutjnl-2023-330980.
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