A US Food and Drug Administration (FDA) advisory panel has voted in favour of approving GRAIL’s Galleri, queuing up a potential landmark approval for the multi-cancer early detection (MCED) test.
In three separate votes, the 10 voting members of the FDA’s Molecular and Clinical Genetics Devices advisory panel considered Galleri’s safety, effectiveness and overall benefit-risk profile for screening for the early detection of multiple types of cancer in adults aged 50 years and older.
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The panel voted seven to two in favour of Galleri’s market approval (with one abstention), concluding that the test’s benefits outweighed its risks, unanimously supported Galleri’s safety profile, and voted six to four in support of Galleri’s effectiveness.
Grail submitted a pre-market approval (PMA) application for Galleri to the FDA on 29 January 2026. The company’s test is designed to detect more than 50 types of cancer from a single blood draw, a target achieved via the detection of cancer-specific methylation patterns shared by many types of cancer, before symptoms appear, including cancers that do not currently have recommended screening protocols in place. It does this by detecting chemical changes in fragments of cell-free DNA (cfDNA) that break off from cancer cells. Galleri secured breakthrough device designation from the FDA in 2018.
Following the panel’s vote, the FDA is now expected to make a final decision on Galleri’s PMA in the coming months.
Grail CEO Josh Ofman commented: “The Galleri test was developed to improve the effectiveness and efficiency of our national cancer screening programme 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.”
Ofman asserted that the panel’s vote reinforced 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,” he concluded.
Panel endorsement follows primary endpoint miss in NHS-Galleri trial
The FDA panel’s endorsement marks a vote of confidence amid a mixed year for the technology. In February, Galleri failed to meet its primary endpoint in a large UK National Health Service (NHS) trial.
Primary results from the NHS-Galleri trial (NCT05611962) were shared at the American Society of Clinical Oncology (ASCO) meeting in Chicago in May, with final results from the randomised trial of over 140,000 patients published in the New England Journal of Medicine on 22 September.
NHS-Galleri sought to determine whether the test’s application in the NHS reduced the likelihood of a late-stage cancer diagnosis in an asymptomatic population. The test’s primary endpoint of statistically significant Stage III/IV reduction in 12 prespecified cancers was not met. Despite this, study investigators highlighted that adding annual MCED testing to standard-of-care (SoC) cancer screening substantially increased screen-detected cancers and reduced Stage IV cancers and emergency presentations, suggesting that integrating MCED into population screening programmes may help reduce late-stage cancer burden.
Also at this year’s ASCO meeting, Grail shared findings from its 35,878-patient registrational PATHFINDER 2 (NCT05155605) study, with results indicating that adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a 6.5-fold increase in the number of cancers found by screening.
Meanwhile, Galleri is being evaluated in the ongoing US-based REACH study (NCT05673018) that is enrolling 50,000 Medicare beneficiaries who have received usual care plus a Galleri test, with a matched comparator arm of beneficiaries who receive usual care alone to assess the test’s real-world clinical impact.
