GRAIL, Inc. said the U.S. Food and Drug Administration (FDA, U.S. drug regulator) has scheduled a Sept. 23, 2026 meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to review the Premarket Approval (PMA, marketing application for medical devices) for its Galleri multi-cancer early detection (MCED, blood-based test for multiple cancers) blood test. Galleri is designed to detect cancer-specific methylation patterns across many cancer types before symptoms appear, including cancers without recommended screening today, and to predict the cancer signal origin with high accuracy when a signal is found. The company said the test is intended to complement, not replace, guideline-recommended screening. GRAIL submitted the application on Jan. 29, 2026, after the FDA designated Galleri a Breakthrough Device in 2018. The filing relies on performance and safety results from 25,490 consented participants with one year of follow up in the U.S.-based PATHFINDER 2 study, data from more than 70,000 participants in the intervention arm of the first-year prevalent screening round of the NHS-Galleri trial, and an analysis comparing earlier study versions of Galleri with the updated PMA version submitted to the agency. CEO Josh Ofman said the company believes adding Galleri to standard screening could improve the effectiveness and efficiency of cancer screening in the United States, while the release said forward-looking statements on benefits, study interpretation and the advisory committee process remain subject to risks and uncertainties.