What Changed at GRAIL

The FDA Molecular and Clinical Genetics Devices Panel voted on GRAIL's Premarket Approval application for the Galleri multi cancer early detection blood test, for screening adults aged 50 and older. The 10 voting members were unanimous on safety, voted 6 to 4 on effectiveness, and voted 7 to 2 with one abstention that benefits outweigh risks. FDA is not bound by the vote and GRAIL expects a final PMA decision in the coming months.

Our read

Galleri is the first multi cancer early detection test to reach a PMA panel, and approval would change its regulatory standing for payers and health systems weighing coverage and adoption. The split 6 to 4 effectiveness vote is the risk to watch before FDA decides.

Nature Medicine published PATHFINDER 2, the registrational US study of Galleri, with 35,878 enrolled and 32,007 participants analyzable for performance. The test showed a 0.54% cancer detection rate, 60.3% positive predictive value, 99.64% specificity, 39.3% episode sensitivity for all cancers (69.8% for a 12 cancer subgroup) and 91.3% cancer signal origin accuracy. Of 35,335 safety analyzable participants, 0.6% had invasive procedures and no serious study related adverse events were reported.

Our read

These are the peer reviewed performance and safety figures behind the PMA, giving buyers a published US intended use benchmark for follow up workload and false positive burden. Results were first presented at ASCO in May 2026, so the change is the peer reviewed publication.

Nature Medicine published Galleri test performance from the randomized NHS-Galleri trial across three annual screening rounds in England. Specificity ranged from 99.50% to 99.60% and cancer signal origin accuracy from 91.1% to 93.6%, while positive predictive value fell from 58.0% to 50.4% to 45.8% across rounds. Episode sensitivity was 26.7% to 37.2% for all cancers and 47.6% to 63.4% for 12 prespecified types.

Our read

This is peer reviewed randomized trial evidence in an intended use population, and the falling predictive value in later rounds bears on the cost of repeat annual screening. The data were first presented at ASCO in May 2026, so the change is the peer reviewed publication.