The U.S. Food and Drug Administration (FDA) will convene the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on September 23, 2026, from 9:00 AM to 6:00 PM ET, in Silver Spring, Maryland, with virtual access also available.

During the open session, the committee will discuss, make recommendations, and vote on GRAIL’s Premarket Approval application for the Galleri® multi-cancer early detection (MCED) blood test.

Galleri is a prescription-only, next-generation sequencing-based test designed to detect cancer-specific methylation patterns in cell-free DNA for early detection of multiple cancers in adults aged 50 and older and to predict the likely origin of a detected cancer signal. This will be the first FDA advisory committee review of a PMA application for an MCED test.