FDA advisory panel recommends Grail's Galleri blood test

On September 23, 2026, the FDA's Molecular and Clinical Genetics Panel recommended approval of Grail's Galleri blood test, a prescription-only test that screens adults aged 50 and older for multiple cancers by reading methylation patterns in cell-free DNA. The panel voted 10-0 that Galleri is safe, 6-4 that it is effective, and 7-2 with one abstention that its benefits outweigh its risks. The FDA is not bound by the vote and is expected to decide in the first part of 2027.

How the review reached the panel

The FDA gave Galleri Breakthrough Device designation in 2018, and an earlier version has been available by prescription in the US since June 2021 under CLIA rules without FDA marketing authorization. Grail submitted its premarket approval application on January 29, 2026. The proposed indication is screening for early detection of multiple cancer types in adults 50 and older; the test returns a "Cancer Signal Detected" or "No Cancer Signal Detected" result and predicts a likely tissue of origin when a signal is found.

In February 2026, Grail disclosed that routine screening with Galleri in the three-year UK trial had not significantly improved early detection or reduced late-stage diagnoses, and shares fell more than 20%. On September 21, FDA staff reviewers released briefing documents that raised no major concerns about accuracy or safety and said there were no outstanding questions on analytical performance, safety or the bridging from an earlier test version. Grail shares rose more than 22% that day.

What the pivotal trials showed

The submission rests mainly on PATHFINDER 2, a North American prospective study with 25,490 participants at one year of follow-up, and NHS-Galleri, a randomized controlled trial in England whose intervention arm contributed over 70,000 participants. Results appeared in Nature Medicine and The New England Journal of Medicine. In PATHFINDER 2, Galleri had 35.0% 12-month episode sensitivity and 99.85% specificity; its false-positive rate was 0.15%, and about 202 people were screened for each cancer detected. In NHS-Galleri, the test detected 259 of 820 new primary cancers (31.6%), but only 97 of 474 stage I or II cancers (20.5%). The UK trial also did not meet its primary endpoint of reducing combined stage III and IV cancers, though Grail later reported that stage IV diagnoses decreased over three years.

That gap drove the central question: FDA advisers were asked whether the evidence supports calling Galleri an "early detection" test. Sensitivity by stage in NHS-Galleri ranged from 13.6% for stage I to 60.0% for stage IV cancer. Phil Castle of the National Cancer Institute told the panel the data were too premature to prove clinical benefit and said, "Routine approval and broad population rollout would risk harm and waste resources". FDA device center director Michelle Tarver called the technology "a genuinely promising opportunity" but said it demands rigorous evaluation.

What the panel decided and what happens next

The panel recommended that marketing materials tell users to continue routine screenings such as colonoscopies and mammograms and avoid characterizing the test as an "early" detection tool. Some members emphasized that Galleri should be additional to, not a replacement for, standard screening. Panel member Victor van Berkel said, "if we can find more early-stage cancers in the population that we can't screen for currently, that will end up having benefit".

Galleri already sells for $949 by prescription, and approval could mean Medicare and private insurance coverage; Congress previously approved Medicare coverage for FDA-greenlighted multi-cancer detection tests. No FDA-authorized device is currently indicated for screening for multiple cancer types. A final FDA decision is expected in the first part of 2027.