FDA advisory panel discussions continued to sharpen the evidence narrative for Grail’s Galleri multi-cancer blood test, with panelists voting that benefits outweigh risks but raising concerns about effectiveness across cancer types and the potential for downstream clinical confusion. Debate centered on false reassurance versus unnecessary follow-up testing. The Molecular and Clinical Genetics devices panel supported the test on safety and narrowly on effectiveness, while also emphasizing that Galleri should not replace guideline-recommended screening pathways. Panelists highlighted the need for patient education and careful interpretation of results, including negative findings. The sector takeaway is regulatory receptiveness to multicancer early detection—yet the evidentiary bar remains sensitive to clinical impact measures, test performance heterogeneity, and how clinicians operationalize the assay in existing screening ecosystems.