An FDA advisory panel backed Grail Inc.’s Galleri multi-cancer early detection blood test, voting that benefits outweigh risks and clearing a key hurdle toward potential premarket approval. The panel also flagged ongoing questions about clinical value and how negative results could affect routine screening behavior. The molecular and clinical genetics devices panel voted in favor of safety and narrowly for effectiveness, with detailed discussion centered on the risk of false positives and false negatives, and the potential for patients to be reassured inappropriately. The test uses methylation pattern analysis in cell-free DNA from a single blood draw, and if a signal is detected, it attempts to identify the likely tissue origin. Clinicians emphasized that Galleri should not replace guideline-recommended screenings for breast, cervical, colorectal, and lung cancers. Public speakers highlighted early-stage cancer detections attributed to the test, but panelists noted limited data for some cancer types and the need for longer-term evidence linking early detection to reduced advanced disease and mortality.