FDA advisory committee set to evaluate Grail's Galleri early-cancer test
The FDA has convened an advisory panel to assess Grail's Galleri multi-cancer detection test.
Regulators will hold a meeting of an expert panel to review data on Grail's Galleri assay, which aims to identify multiple cancers early. The discussion will focus on the test's performance, safety profile, and potential clinical use. Grail hopes the panel's feedback will guide a possible market authorization. The outcome could influence how the test is integrated into routine screening.
Why it matters
FDA review will determine if Galleri can become a widely used tool for early cancer detection.
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FDAadvisory panelGalleriGrailcancer detection testbiotechregulatory review