Grail said the U.S. Food and Drug Administration (FDA) plans to convene a meeting of outside experts on Sept. 23, 2026, to review the company’s premarket approval (PMA) application for its Galleri multi-cancer early detection blood test. The company said the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to evaluate the application under the agency’s PMA pathway, the most stringent review process for medical devices.
The advisory committee will assess the data submitted in support of Galleri, although the FDA is not required to follow the panel’s recommendation when making its final decision.
Review Follows Results From UK Cancer Screening Trial
The regulatory review follows results released earlier this year from a three-year trial in the United Kingdom. According to the findings, Galleri did not significantly improve early cancer detection or reduce diagnoses at later stages of disease.
Grail submitted its PMA application to the FDA on Jan. 29, 2026.
Galleri is a blood-based cancer screening test intended to detect signals associated with more than 50 cancers from a single blood sample. The test is designed to identify cancer-specific methylation patterns that are shared by many types of cancer before symptoms appear.
When a cancer signal is detected, the test is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. Grail said the test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.
Data Included in the Premarket Approval Submission
The PMA application is supported by data from multiple clinical studies. According to the company, the submission includes test performance and safety results from 25,490 consented participants with one year of follow-up in the U.S.-based PATHFINDER 2 study.
The application also includes data from more than 70,000 participants from the intervention arm of the prevalent screening round, the first year of the NHS-Galleri trial. Grail described the study as the largest and only randomized, controlled trial of a multi-cancer early detection test in an intended-use population.
In addition, the submission contains an analysis comparing the version of Galleri used in the PATHFINDER 2 study and the NHS-Galleri trial with the updated PMA version submitted to the FDA for premarket approval.
Company Comments Ahead of the September Meeting
Commenting on the upcoming review, Josh Ofman, MD, MSHS, chief executive officer of Grail, said, “Galleri is the only MCED test supported by large interventional and randomized, controlled studies in intended use populations.”
Ofman also said the company appreciates the FDA’s leadership in advancing the review of what Grail described as the first premarket approval application for a multi-cancer early detection test and looks forward to discussing Galleri’s clinical data with the Advisory Committee.
The FDA designated Galleri as a Breakthrough Device in 2018. The advisory committee meeting is scheduled for Sept. 23, 2026, to review the PMA application for the Galleri multi-cancer early detection blood test.
Galleri Heads Toward FDA Advisory Review
Galleri is set to receive attention from an FDA advisory panel in September as experts review the multi-cancer blood test developed by Grail.
Multi-cancer blood testing is emerging as an area of interest in oncology because it could potentially provide information about several cancer types from a single blood sample. Traditional screening programs generally focus on individual cancers and use different tests depending on the disease.
A broader testing approach could complement established screening methods, particularly if future research demonstrates that it can detect disease early enough to improve outcomes.
Key Questions for Regulators
Regulators and medical experts are likely to examine several important issues when evaluating a multi-cancer detection technology. These include how accurately the test identifies cancer, how often it produces incorrect results, and how clinicians should respond to abnormal findings.
Another important consideration is whether earlier detection actually leads to better survival or quality-of-life outcomes. A screening technology must provide meaningful clinical benefits rather than simply identifying more abnormalities.
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