An FDA advisory panel endorsed Grail’s Galleri multicancer early detection blood test, concluding that benefits outweigh risks. The panel voted 10–0 that the test is safe and 6–4 that there is reasonable assurance of effectiveness, while also emphasizing that results should not replace guideline-recommended cancer screening. Debate at the meeting focused on potential false reassurance, the risk-benefit balance, and the clinical pathway for follow-up testing when a signal is detected. Multiple panelists and public commenters stressed that a negative result does not definitively rule out cancer. For the biotech and diagnostics market, the recommendation is a key procedural step toward possible FDA authorization, and it spotlights the evolving regulatory posture toward methylation-based liquid biopsies.