FDA Panel to Vote on Grail's Galleri Cancer Test

FDA's Molecular and Clinical Genetics Panel meets Sept. 23, 2026, to discuss, make recommendations and vote on GRAIL's premarket approval application for Galleri, a sequencing-based test to detect cancer-specific methylation patterns. GRAIL submitted the application Jan. 29, 2026, and says FDA designated Galleri a Breakthrough Device in 2018.