On September 23, 2026, the FDA's Molecular and Clinical Genetics Devices Panel voted on GRAIL's application for premarket approval of the Galleri multi-cancer early detection test in adults 50 and older. As reported, the panel was unanimous that the test is safe, voted 6–4 that the evidence supports its effectiveness, and voted 7–2, with one abstention, that its benefits outweigh its risks (Epocrates; GRAIL). Reported sensitivity for stage I cancers was 21.4 percent and 13.6 percent in the two pivotal studies, against about 60 percent for stage IV. Results of the NHS-Galleri trial and the PATHFINDER 2 study were published on September 22 (CancerNetwork).
What a clinician can tell a patient now. A panel vote is advisory; the FDA has not decided. The test remains available only as a prescription laboratory-developed test. It does not replace guideline screening such as colonoscopy, mammography, cervical screening or low-dose CT where indicated. A positive result requires a diagnostic work-up. A negative result does not rule out cancer, particularly early-stage cancer. A reduction in deaths from cancer has not been demonstrated.