The FDA will convene an advisory committee meeting in September to review Grail’s Galleri, a blood-based multi-cancer early detection test that failed to meet the primary endpoint in a large randomized trial in the UK. The move keeps pressure on the evidentiary bar for MCEDs after scrutiny of performance claims and clinical utility. Grail said it submitted an updated application using data including PATHFINDER 2 and NHS-Galleri cohorts, plus bridging analyses to compare earlier versions of Galleri. Payors and employers have signaled coverage decisions depend heavily on the FDA’s outcome and advisory guidance. The September meeting could become a pivotal gating step for future MCED development and funding decisions in the early detection category.