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Guardant Health’s FDA-approved Shield™ Blood Test Now Commercially Available in U.S. as a Primary Screening Option for Colorectal Cancer
FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening of colorectal cancer and meets coverage
About this update from Guardant Health, Inc.
[{"type":"text","content":"\n\nFDA approval announced earlier this week makes Shield first blood test that is approved for primary screening of colorectal cancer and meets coverage requirements for Medicare reimbursement\n\n\n\nCommercial launch of Shield and CMS coverage make blood-based screening option more accessible to millions of individuals at average risk for the disease\n\n\n\n PALO ALTO, Calif.--(BUSINESS WIRE)--\nGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield™ blood test, recently approved by the U.S. Food and Drug Administration (FDA), is now covered by Medicare and is commercially available in the U.S. as the first FDA-approved blood test for primary colorectal cancer (CRC) screening.\n\n\nThe Centers for Medicare & Medicaid Services (CMS) now covers the Shield test based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests (NCD 210.3). The test is covered once every three years for eligible Medicare beneficiaries.\n\n\n“The commercial launch of the Shield test and Medicare coverage make it possible for millions of eligible individuals to access a convenient, more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated,” said AmirAli Talasaz, Guardant Health co-CEO. “From day one, Shield will be covered for more than 45 million Medicare beneficiaries, including many who are non-compliant with colonoscopy. This represents both a major step forward in the fight against colorectal cancer and a significant opportunity for Guardant Health. We also look forward to the process of getting Shield included in clinical guidelines to support private payer coverage, which will enable even broader and more equitable access.”\n\n\nCommercial insurance coverage for patients eligible for CRC screening will continue to expand pending future review and inclusion in guidelines by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF).\n\n\nThe Shield test received FDA approval as a primary non-invasive option for CRC screening in average-risk adults age 45 and older. The FDA approval was based on results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Results from ...