The U.S. FDA has scheduled a Sept. 23, 2026 meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to review Grail’s premarket approval application for its Galleri multi‑cancer early detection (MCED) blood test.
Grail’s Galleri test is a prescription‑only, next‑generation sequencing–based blood test that analyzes cell‑free DNA methylation patterns to screen for multiple cancers in adults aged 50 and older, and to predict where a detected cancer signal may have originated.
The test is currently marketed as a laboratory‑developed test (LDT), is not yet FDA‑approved, and is available for order by clinicians in the United States, but major health organizations caution that more research and evidence are needed before it can be recommended for widespread population screening.
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Multi-cancer Detection (MCD) Tests | American Cancer Society