An FDA advisory committee has voted in favor of approving Galleri, a multi-cancer early detection (MCED) test developed by Sunnyvale, California-based GRAIL, Inc. (Nasdaq: GRAL), bringing the test a step closer to becoming the first MCED test to receive US FDA premarket approval (PMA).
The Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee cast three separate votes on September 23, 2026, covering Galleri's safety, effectiveness, and overall benefit-risk profile for screening adults aged 50 years and older for multiple cancer types. The panel voted seven to two with one abstention that the benefits of Galleri outweigh its risks, voted unanimously in support of its safety, and voted six to four in support of its effectiveness. The FDA is expected to issue a final decision on the Galleri PMA in the coming months.
Galleri is designed to detect cancer-specific methylation patterns shared across many cancer types before symptoms appear, including cancers for which no recommended screening currently exists. When a cancer signal is detected, the test is designed to predict the cancer signal origin with high accuracy to guide diagnostic evaluation, and is intended to be used alongside, not as a replacement for, existing guideline-recommended screenings. This additive positioning — supplementing rather than displacing established screening programs — was central to how GRAIL framed the benefit-risk case before the panel.
GRAIL submitted its PMA application to the FDA on January 29, 2026, and the FDA had designated Galleri as a Breakthrough Device in 2018. The advisory panel review followed an announcement in August 2026 that the committee meeting had been scheduled, as covered previously by AllSci.
The clinical evidence package underpinning the PMA drew on two large prospective studies. PATHFINDER 2, which enrolled more than 35,000 participants, reported that Galleri increased cancer detection 6.5-fold when added to recommended screenings for breast, colorectal, cervical, and lung cancer, with 71% of newly detected cancers found at stages I–III. The NHS-Galleri trial, conducted in England, reported that annual Galleri testing reduced stage IV diagnoses of 12 prespecified cancers by 22% and 26% in the second and third screening rounds, respectively, though no reduction was observed in the combined primary endpoint of stage III/IV cancers in aggregate. Both studies were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. GRAIL said both studies were conducted under FDA-approved Investigational Device Exemption protocols.