A blood test that can scan for signals from up to 50 different cancer types in a single vial of blood is now under formal FDA review. GRAIL, Inc. submitted the final module of its Premarket Approval application to the FDA in January 2026 for its Galleri multi-cancer early detection test, marking the most advanced regulatory step yet toward routine clinical use of what the company and many oncologists consider a potentially transformative screening tool.
If the FDA approves the test, it could reshape how the United States approaches cancer screening for adults over 50 — and could eventually be covered by Medicare as early as 2028, according to GRAIL's president.
