Galleri Multi-Cancer Blood Test Gains FDA Panel Support

An FDA advisory panel recently reviewed the Galleri multi-cancer blood test, marking a notable step in the evaluation of new cancer screening technologies in the United States.

The Galleri test, developed by Grail Inc., is intended to identify cancer signals from a single blood sample and is currently designed for individuals aged 50 and older. This test aims to supplement, rather than replace, existing cancer screening approaches that typically target individual cancer types.

On September 23, 2026, the FDA advisory panel voted unanimously that Galleri is safe, with a 10-0 outcome. The panel also determined by a 6-4 vote that there is reasonable assurance of the test’s effectiveness. In a separate vote, the group concluded 7-2, with one abstention, that the benefits of the test outweigh its risks for the proposed use.

Galleri has not yet received FDA approval, and no multi-cancer early detection tests have been authorized by the agency to date. The FDA considers the recommendations of its advisory panels but is not required to follow them when making final decisions.

What the numbers show

• Over 35,000 participants were included in a published study of Galleri.
• Galleri detected cancer signals in 287 people, with about 60% later confirmed to have cancer.
• The test correctly identified the tissue of origin in approximately 91% of detected cases.

Galleri is currently available as a laboratory-developed test under CLIA regulations, but it does not have FDA approval or endorsement in clinical guidelines. The American Cancer Society has stated that existing screening tools are designed for single cancers, and no multi-cancer early detection tests have been approved by the FDA as of November 2024.

The primary evidence supporting Galleri’s regulatory submission includes data from the PATHFINDER 2 study, which enrolled 35,878 participants, and the NHS-Galleri trial. An earlier interventional study, PATHFINDER 1, involved 6,662 participants in the United States and evaluated the test’s performance and diagnostic follow-up procedures.

According to company statements, if the test receives approval, it would be used alongside established screening methods. The current out-of-pocket cost for the Galleri test is $949, and clearing the advisory panel review could affect future reimbursement options, including potential Medicare coverage.

Experts have stated that further research is needed to determine whether the use of Galleri reduces the incidence of advanced cancers and cancer-related deaths. The test is not intended as a replacement for current screening standards but as an additional tool for early detection.

* This article is based on publicly available information at the time of writing.