The committee voted 7-2 that the benefits of the screening test outweigh its risks for adults aged 50 and older.
An advisory panel to the US Food and Drug Administration (FDA) has voted in favor of approving GRAIL’s premarket approval application for the Galleri multi-cancer early detection test.
The Molecular and Clinical Genetics Devices Panel of the Medical Devices Advisory Committee evaluated the blood 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 10-member panel voted 7-2 with one abstention that Galleri’s benefits outweigh its risks, voted unanimously in favor of its safety, and voted 6-4 in support of its effectiveness.
“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,” says Josh Ofman, MD, MSHS, CEO at GRAIL, in a release. “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.”
How the Test Works
The Galleri assay is designed to identify cancer-specific methylation patterns shared across multiple cancer types before clinical symptoms manifest, including malignancies that lack guideline-recommended screening options. When a positive cancer signal is detected, the test predicts the cancer signal origin with high accuracy to guide subsequent diagnostic workups.
The test is intended to complement, rather than replace, standard guideline-recommended cancer screenings.
Clinical Trial Evidence
Galleri’s clinical development program includes FDA-approved investigational device exemption studies, including PATHFINDER 2 in North America and the NHS-Galleri trial in England. In clinical evaluations, the test detected approximately four to seven times more cancers than standard care alone, with the majority of screen-detected cancers identified at earlier stages while maintaining a low false-positive rate and high cancer signal origin prediction accuracy.
“We are heartened by the more than 200 physicians, nurses, professional societies, patients, patient advocates, and others who shared their support for Galleri through the written public docket and open comment period during the panel,” says Ofman, in a release. “Their voices reflect the real-world urgency of finding more cancers, when outcomes can be improved.”
Regulatory Outlook
The FDA granted breakthrough device designation to Galleri in 2018, and GRAIL submitted its premarket approval application on Jan 29, 2026.
While the FDA is not bound by the advisory committee’s recommendations, the agency considers the panel’s input during its review process. A final regulatory decision on the premarket approval application is expected in the coming months.
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