FDA Panel To Vote On First Multi-Cancer Blood Screening Test

An FDA medical device advisory committee will vote on recommending approval of Grail's Galleri multi-cancer blood test on Wednesday, September 23, 2026, at an agency advisory meeting.^[1]

Panelists will weigh large trials, including a U.K. National Health Service study of more than 140,000 people and a North American study of over 35,000 adults age 50 and older.^[1] Those studies produced mixed evidence on whether the test reduced deaths or caught cancers at earlier stages.^[1]

Grail markets Galleri as a single blood draw that can detect signals from up to 50 cancer types and says it is meant to supplement, not replace, standard screenings such as colonoscopies and mammograms.^[1] Galleri currently sells for $949, and a recent change in Medicare law would allow coverage for multi-cancer detection tests that receive FDA approval, which could quickly widen access and affect pricing.^[1]

An advisory committee vote does not bind the FDA, but a recommendation in favor would be a major step toward approval and would likely prompt rapid coverage and practice changes if regulators follow the panel.

1. NPR