FDA advisory panel endorses Grail's Galleri multicancer blood test

An FDA advisory panel has endorsed Grail Inc.'s Galleri multicancer blood test, voting 7-2 that its benefits outweigh its risks. While the panel voted unanimously that the test is safe, members split 6-4 on its effectiveness. The decision comes despite significant reservations from oncologists, as the test failed its primary endpoint in a major 140,000-patient UK trial. Currently sold out-of-pocket for up to $949, FDA approval would pave the way for Medicare and private insurance coverage.

FDA advisory panel vote details

• ▪An FDA advisory panel voted on September 23, 2026, to endorse Grail Inc.'s Galleri multicancer blood test, concluding that its probable benefits outweigh its risks.
• ▪The FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee reviewed Grail Inc.'s Galleri test on September 23, 2026, to evaluate its safety, effectiveness, and benefit-risk profile.
• ▪The FDA advisory panel voted 7-2, with one member abstaining, that the probable benefits of Grail Inc.'s Galleri test outweigh its risks for patients meeting the proposed criteria.
• ▪The FDA advisory panel voted unanimously 10-0 that Grail Inc.'s Galleri test is safe, but voted narrowly 6-4 that there is reasonable assurance the test is effective.

Expert skepticism over test benefits

• ▪Phil Castle, director of the National Cancer Institute's Division of Cancer Prevention, warned the panel that broad rollout of the Galleri test risks harm and wasted resources due to premature performance data.
• ▪Dr. Victor van Berkel of the University of Louisville stated his affirmative vote was hopeful rather than accurate, noting that the benefit of finding early-stage cancers with the test has not yet been proven.

Design and intended use of the test

• ▪The Galleri test is intended to complement and be used in addition to standard, guideline-recommended cancer screenings, such as mammograms and colonoscopies, rather than replacing them.
• ▪Grail Inc.'s Galleri test is designed to screen a single blood sample for more than 50 types of cancer by analyzing methylation patterns in cell-free DNA shed into the bloodstream.

Nature Medicine study

• ▪The Grail-funded study published in Nature Medicine on September 22, 2026, found that more than half of the cancers caught by Grail's Galleri test were early stage, and most lacked routine screening.
• ▪A Grail-funded study of over 32,000 adults aged 50 and older, published in Nature Medicine on September 22, 2026, found that about 60% of participants with a positive Galleri result were confirmed to have cancer.

UK clinical trial results

• ▪Grail Inc.'s Galleri test failed to meet its primary endpoint of reducing combined Stage III and IV cancer diagnoses in a pivotal three-year clinical trial involving over 140,000 participants with the UK's National Health Service.
• ▪Dr. Scott Ramsey of the Fred Hutchinson Cancer Center stated that the UK National Health Service trial results call the Galleri test's early-detection value into question and noted there is no proof it reduces cancer mortality.

Current availability and impact of approval

• ▪Grail Inc. has sold the Galleri test in the United States since 2021 as a laboratory developed test without FDA approval, with patients typically paying out-of-pocket costs ranging from $700 to $949.
• ▪FDA approval of the Galleri test would enable widespread distribution, physician guideline adoption, and routine insurance coverage, including Medicare coverage authorized by Congress to begin in 2028.

Debatable claims

• ▪The FDA should approve Grail's Galleri multi-cancer blood test
• ▪Routine Medicare coverage for Grail's Galleri test is justified
• ▪A reduction in cancer mortality is the only reliable measure of a screening test's value