FDA Panel Votes on Grail's Galleri Cancer Test

FDA's Molecular and Clinical Genetics Panel meets Sept. 23, 2026 to discuss, recommend and vote on Grail's premarket approval application for Galleri, a sequencing-based test — it scans DNA — to spot cancer-specific methylation patterns, chemical markers. Grail filed Jan. 29, 2026. Grail says FDA designated it a Breakthrough Device in 2018.