Grail told investors at JP Morgan that it plans to submit its Galleri multi‑cancer early detection test to the FDA for premarket approval in Q1 2026 and projected full‑year 2025 revenue growth of roughly 17–18% to $147–148 million. The company reported Galleri commercial volumes of more than 185,000 tests in 2025, a 35% increase year‑over‑year, and said repeat testing and prescriber growth support demand. Grail also raised testing capacity to 1 million tests per year and expects further dataset releases mid‑2026 from large trials such as the NHS‑Galleri study. Grail is positioning Galleri for regulatory clearance while scaling commercial operations and preparing to present full trial datasets in mid‑2026. The development matters for payers, providers and diagnostics labs because an FDA‑cleared MCED test would change reimbursement and clinical adoption dynamics for population screening.