Grail submitted a PMA application to the FDA seeking premarket approval for its multi‑cancer early detection blood test Galleri, citing performance and safety data from more than 25,000 patients across the Pathfinder 2 study and the first year of the NHS‑Galleri pilot. The submission focuses on analytical validity, clinical performance and safety endpoints. Grail’s regulatory filing marks a high‑profile test of multi‑cancer early detection technologies as developers seek formal approval beyond emergency or laboratory‑developed test pathways. Regulators will scrutinize sensitivity, specificity, false‑positive burden and downstream clinical workflows for positive results. If cleared, Galleri could accelerate adoption of population‑level early cancer screening, but payers and clinical groups will evaluate clinical utility, cost, and implementation pathways before routine integration into screening programs.