Seven to two, with one abstention. That was the margin by which an FDA advisory panel decided on 23 September that the benefits of GRAIL’s Galleri blood test outweigh its risks. It is the first time a multi-cancer early detection test has gone before such a panel.
The ten voting members of the Molecular and Clinical Genetics Devices Panel took three separate votes, all on screening adults aged 50 and older. On safety they were unanimous. On effectiveness the split was six to four.
What Galleri does
The test looks in the blood for methylation patterns that many cancers share, before symptoms show, including cancers with no recommended screening today. If it finds a signal, it also predicts where in the body the cancer started, to point doctors toward the right follow-up. GRAIL says it is meant to sit on top of mammograms, colonoscopies and other guideline screening, not replace them. It is already sold by prescription at $949, according to NPR.
The case for and against
GRAIL’s chief executive, Josh Ofman, said the vote “reinforces the strength of Galleri’s clinical evidence.” The company points to two large studies, PATHFINDER 2 in North America and the NHS-Galleri trial in England, and says the test found roughly four to seven times more cancers than standard care alone, mostly at earlier stages. It also reports more than 200 written and spoken comments in support.
The meeting was not one-sided. NPR reported that the NHS study, which enrolled more than 140,000 people, did not cut deaths overall or meet its main goal of reducing combined Stage III and IV diagnoses. GRAIL later said Stage IV diagnoses alone fell over the three years. Phil Castle of the National Cancer Institute told the panel that routine approval and broad rollout “would risk harm and waste resources,” warning that people could be falsely reassured. The panel itself recommended that marketing urge people to keep up other screening and avoid calling Galleri an “early” detection tool.
Michelle Tarver, who heads the FDA’s devices center, called the concept “a genuinely promising opportunity” but said such technology demands careful, rigorous evaluation.
What comes next
The vote is advice only. The FDA is not bound by it, and the agency has given no date for its decision on GRAIL’s application, filed on 29 January 2026; GRAIL expects a ruling in the coming months. The device has had Breakthrough designation since 2018.
Anyone weighing a test like this should talk to their doctor first. Galleri does not replace the screening you are already due, and a negative result does not rule out cancer.
Sources
- FDA Advisory Committee Votes In Favor of Approval of GRAIL’s Galleri<sup>®</sup> Multi-Cancer Early Detection Test – GRAIL
- FDA advisory panel recommends a first: multi-cancer blood test
- FDA Advisory Panel Votes to Approve GRAIL Galleri MCED Screening Test | Oncology Nursing News
