FDA Advisory Committee Convenes to Review GRAIL's Galleri Multi-Cancer Early Detection Blood Test — Panel Notes Trial Missed Its Primary Mortality-Reduction Endpoint

The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met at the White Oak campus to review and vote on GRAIL's premarket approval application for Galleri, a blood-based test that screens cell-free DNA methylation patterns for signals of up to 50 cancer types, including many with no recommended screening today. The committee reviewed data from two major studies — more than 140,000 participants in the UK's NHS-Galleri trial and over 35,000 North American participants (PATHFINDER 2) — covering adults 50 and older. FDA briefing documents released ahead of the meeting showed the trials did not meet their primary endpoint of reducing overall mortality, nor did they reduce the combined rate of Stage III/IV cancer diagnoses, though GRAIL noted Stage IV diagnoses alone fell over the three-year study period. Galleri is already sold as a $949 lab-developed test; FDA approval would be a prerequisite for Medicare reimbursement, which Congress has authorized for FDA-approved multi-cancer detection tests. The panel's recommendation is non-binding; a final FDA decision was not announced as of this report.