The FDA has recommended that it approve Guardant Health’s blood-based colon cancer detection test, which is a significant step towards wider acceptance and use of the test. The panel comprised of experts carefully reviewed presentations from Guardant, the FDA, and members of the public before voting on the screening test known as Shield. Nine panel members then voted on the safety and efficacy of the test, with a majority endorsing its safety, effectiveness, and benefits outweighing its risks.
This approval is crucial for gaining coverage from the Centers for Medicare and Medicaid Services (CMS), which could determine whether or not the test becomes widely available. In the past, CMS denied coverage for a different blood-based colon cancer test, Epi proColon, shortly after FDA approval. This led to Epigenomics halting marketing efforts and undergoing restructuring that included layoffs.
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