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RegulationSeptember 24, 2026

FDA panel endorses GRAIL’s multi-cancer early detection test

An FDA advisory panel voted 7-2 to endorse GRAIL's Galleri multi-cancer early detection test, finding that its clinical benefits outweigh risks. The panel's recommendation supports the company's pathway toward potential regulatory clearance for this blood-based screening assay designed to detect multiple cancer types in asymptomatic individuals.

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