Grail filed a premarket approval (PMA) submission for its Galleri multi‑cancer early detection test, centering the dossier on performance and safety data from more than 25,000 participants in Pathfinder‑2 and first‑year results from the NHS‑Galleri study. The submission seeks clearance for the blood‑based test to detect multiple cancer types in asymptomatic populations. Grail’s application focuses on analytic and clinical performance metrics, false‑positive rates and safety, and includes large prospective cohorts — a key regulator expectation for screening tests. If accepted, the PMA would set a precedent for high‑throughput multi‑cancer early detection assays seeking US market entry. Regulatory review will hinge on population‑level benefit, follow‑up pathways, and real‑world implementation strategies; payers and health systems are watching for FDA determinations that could affect coverage and uptake.