ASCO will not recommend Grail’s Galleri multi-cancer early detection test for inclusion in cancer screening guidelines after reviewing data from a large prospective randomized trial. The organization cited that the trial failed to meet its primary endpoint despite additional findings showing fewer late-stage cases and more early detections after three years. ASCO’s chief medical officer, Julie Gralow, said the results are encouraging but concluded the evidence does not yet support guideline adoption. This sets up continued reliance on early access programs rather than broad screening recommendations while evidence standards are debated. For biotech and clinical diagnostics developers, the decision highlights how endpoint requirements and health-system implementation questions continue to shape the commercialization path for MCED tools.