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 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

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) 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.

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Source: Guardant Health, Inc.