An independent panel of FDA advisers recommended approving Guardant Health’s blood-based colon cancer test, called Shield. The panel voted on the test’s safety, effectiveness, and risk-benefit balance with positive outcomes. FDA approval is crucial for coverage by Centers for Medicare and Medicaid Services, determining the test’s widespread adoption. In contrast, CMS denied coverage for another blood-based colon cancer test, leading to the discontinuation of marketing by its maker, Epigenomics. Guardant’s test could face a similar fate without FDA approval. This decision highlights the importance of regulatory approval in determining the success of medical tests in the market.
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Guardant Health colon cancer test endorsed by FDA advisory panel
