Grail submitted a premarket approval application to the FDA for its Galleri multi‑cancer early detection (MCED) blood test, citing performance and safety data from more than 25,000 patients in the Pathfinder 2 trial plus early results from NHS‑Galleri. The filing focuses on sensitivity, specificity, and clinical validation across multiple cancer types. The application marks a pivotal regulatory step for population‑scale liquid biopsy screening. Grail’s submission leverages large prospective cohorts and the NHS pilot to argue for clinical-grade performance that could support broader implementation if approved. Regulators will weigh the test’s positive predictive value across low‑prevalence cancers, clinical utility in shifting diagnostic pathways, and integration with existing screening programs; an FDA decision would set a precedent for MCED regulatory pathways and payer coverage discussions.