An FDA advisory committee session raised questions about the effectiveness of Grail’s next-generation sequencing blood test for early detection of multiple cancers in adults over 50. FDA’s Molecular and Clinical Genetics Panel members and agency officials focused on the evidence base for performance claims. The discussion reflects heightened scrutiny of multi-cancer early detection claims as regulators and clinical stakeholders push for clarity on sensitivity, specificity and real-world outcomes. Grail’s next-generation test would be evaluated on its ability to identify cancer early enough to improve patient prognosis while avoiding excessive false positives. The advisory feedback increases uncertainty around the regulatory trajectory for broad screening applications, even as the technology remains an important strategic direction for blood-based oncology diagnostics.