An FDA advisory panel recommended moving Grail’s Galleri multicancer early detection test forward, voting that probable benefits outweigh risks while raising concerns about false reassurance and screening behavior. The molecular and clinical genetics panel supported safety, but narrowly supported effectiveness, with the vote reflecting continuing debate over the strength of clinical benefit. Galleri is based on a single blood draw analyzing methylation patterns in cell-free DNA to flag cancer signals and infer tissue origin. Panelists emphasized the test should not replace guideline-recommended screening, including for breast, cervical, colorectal and lung cancers. Analysts cited the panel decision as a leading indicator for FDA approval while noting that committee discussion centered on limitations in data across cancer types and the downstream clinical management of patients with negative results.