An FDA advisory panel voted in favor of Grail’s Galleri multi-cancer early detection blood test, concluding that benefits outweigh risks for adults meeting the proposed indication criteria. In the panel vote, members unanimously supported safety and split on effectiveness, with the overall risk–benefit assessment landing in Grail’s favor. The test is being evaluated as an early signal detector for multiple malignancies before symptoms appear, with an FDA review process now moving forward from the advisory stage. In the pivotal Nature Medicine study cited in the discussion, Galleri detected signals in a subset of participants later diagnosed with cancer and showed ability to predict the cancer origin site in most positive cases. Even with the endorsement, experts emphasized the screening tradeoffs: a negative result does not definitively rule out cancer, and the key unanswered question remains whether earlier detection translates to fewer advanced cancers and reduced mortality.