FDA advisory panel narrowly endorses Grail's Galleri multi-cancer blood test

Advisory panel vote

The US Food and Drug Administration's Medical Devices Advisory Committee voted on Wednesday to endorse Galleri, a blood-based multi-cancer early detection screening produced by California-based biotech Grail. The 10-person panel voted unanimously 10-0 that the test is safe. On the question of whether the test's benefits outweigh its risks, the panel voted 7-2 in favor, with one member abstaining. On clinical effectiveness, the panel divided more narrowly, voting 6-4 to affirm that the screening is effective.

Mechanism and clinical trial results

Galleri identifies fragments of DNA circulating in blood samples to detect signs of more than 50 cancer types before symptoms develop, including stomach, bladder, colorectal, skin, and breast cancers. The test has been commercially available in the United States since 2021 without formal FDA approval. However, panel members noted concerns regarding diagnostic accuracy, false positive rates, and the test's ability to detect early-stage malignancies. A trial conducted with the UK National Health Service involving more than 142,000 individuals showed no statistically significant reduction in late-stage cancer diagnoses among tested participants compared to a control group, a finding announced earlier in 2026.

Panel reactions and expert concerns

Members of the advisory committee expressed mixed views during deliberations, noting the potential utility of detecting tumor types that lack standard screening procedures while pointing to gaps in supporting evidence. Victor van Berkel, division chief of thoracic surgery at the University of Louisville, supported the test despite reservations.

If we can find more Stage 1 or more early-stage cancers in a population that we can't screen for currently, then that will end up having benefit. But I don't know that that's been proven yet. So perhaps my 'yes' is a hopeful [vote] rather than an accurate one.

Jason Dominitz, a gastroenterologist at the University of Washington who also voted in favor, expressed similar concerns about regulatory clearance during the panel review.

I have serious concerns about approving this test.

Corporate background and market response

The advisory vote follows corporate reorganizations and market volatility for Grail. Spun off from genetic sequencing firm Illumina in 2016, Grail was reacquired by Illumina in 2021 despite regulatory opposition in the US and the European Union. That transaction resulted in a boardroom dispute with activist investor Carl Icahn in 2023. In February 2026, Grail shares fell nearly 50% following the release of the NHS clinical trial data. Ahead of the advisory meeting on Monday, Grail shares gained more than 30% before trading was halted on Wednesday. The stock is up 27% since the start of 2026.

Regulatory next steps

Advisory committee votes are nonbinding recommendations, leaving the final regulatory determination to the FDA itself. Grail said it anticipates an agency decision in the coming months. Grail is also listed as a top sponsor for an event organized by the Make America Healthy Again movement. Grail chief executive Josh Ofman defended the clinical standing of the screening following the advisory session.

We believe the panel's recommendations reaffirm a high evidence bar that Grail has set for a multi-cancer early detection test.