Multi-Cancer Early Detection Test Wins FDA Panel Backing for Approval

GRAIL’s Galleri multi-cancer early detection (MCED) test was reviewed by the Molecular and Clinical Genetics Devices Panel of the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee. The panel’s 10 voting members considered the test’s safety, effectiveness, and overall benefit–risk profile for screening multiple cancer types in adults aged 50 years and older. In three separate votes, the panel voted 7–2, with one abstention, that the benefits outweigh the risks; unanimously that the test is safe; and 6–4 that it is effective.

Galleri is designed to detect cancer-specific methylation patterns shared across multiple cancer types before symptoms appear, including cancers for which no recommended screening currently exists. When a cancer signal is detected, the test also predicts the likely Cancer Signal Origin to help guide subsequent diagnostic evaluation. Galleri is intended to complement, rather than replace, guideline-recommended cancer screening.

Image: Galleri is designed to detect cancer-specific methylation patterns across multiple cancer types before symptoms appear, including cancers without recommended screening (Photo courtesy of GRAIL)

The test has been evaluated in large interventional and randomized controlled studies involving intended-use populations, including the U.S. Food and Drug Administration Investigational Device Exemption (IDE) PATHFINDER 2 study in North America and the NHS-Galleri trial in England. Across clinical studies, Galleri has detected approximately four to seven times more cancers than standard-of-care screening alone, with many Galleri-detected cancers identified at earlier stages while maintaining a low false-positive rate and high Cancer Signal Origin prediction accuracy. GRAIL has also submitted Galleri through the FDA’s premarket approval (PMA) pathway, representing the first PMA submission for an MCED test.

Galleri received Breakthrough Device designation in 2018, and GRAIL submitted its PMA application on January 29, 2026. The FDA convenes advisory committees to obtain independent expert advice and is not bound by their recommendations, although it considers them in final regulatory decisions. A final decision on the Galleri PMA is expected in the coming months.

“The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening program by adding multi-cancer early detection to recommended screening—helping find more cancers safely, when they may be easier and less costly to treat, and it still may be possible for a patient to receive treatment with curative intent,” said Josh Ofman, M.D., M.S.H.S., chief executive officer at GRAIL.

 "Today's vote reinforces the strength of Galleri's clinical evidence. We believe the panel's recommendations reaffirm a high evidence bar that GRAIL has set for a multi-cancer early detection test. GRAIL is committed to working with the FDA as it completes its review of Galleri, the first PMA submission for a multi-cancer early detection test," said Ofman. 

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