Officials with Guardant Health, Inc, announced on August 1 that its blood test(Shield, Guardant Health) has been FDA approved and is now covered by Medicare as the first blood test for primary colorectal cancer (CRC) screening.
The Centers for Medicare and Medicaid Services (CMS) now covers the 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 3 years for eligible Medicare beneficiaries.
Commercial insurance coverage for patients eligible for CRC screening is pending future review and inclusion in guidelines by the American Cancer Society and the United States Preventive Services Task Force (USPSTF), the company said in a press release.
The approval was based on results from ECLIPSE, a 20,000+ patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of current guideline-recommended noninvasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.
Healthcare providers can have patients complete a test with a blood draw during a routine office visit, with test results available approximately 2 weeks is received at the Guardant Health lab.
For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.1
Editor’s note: This report was based on statements issued by the FDA and the pharmaceutical companies involved in the approvals.