Grail submitted its Galleri multi‑cancer early detection blood test for FDA premarket approval, citing performance and safety results from over 25,000 patients in the Pathfinder 2 study and interim NHS‑Galleri data. The filing aims to move the cell‑free DNA assay from validation studies into regulated clinical availability. If cleared, Galleri could change screening paradigms by enabling multi‑cancer detection from a single blood draw; the submission will focus scrutiny on specificity, positive predictive value and real‑world implementation.