Grail submitted a premarket approval application to the FDA for its Galleri multi‑cancer early detection (MCED) test, citing performance and safety data from more than 25,000 Pathfinder 2 patients and initial NHS‑Galleri results. The filing targets a regulatory pathway that would allow clinical deployment in the U.S. The application focuses on analytical and clinical performance across multiple cancer types and describes safety and false‑positive mitigation strategies. Grail’s submission hinges on demonstrating clinical validity and acceptable tradeoffs between sensitivity and specificity in population screening contexts. If cleared, Galleri would represent a landmark regulatory decision for MCED diagnostics, with implications for screening paradigms, payer coverage, and integration of cfDNA‑based tests into standard oncology workflows.