U.S. — FDA staff members reported no major concerns or questions regarding the safety, accuracy, risks, or benefits of the Galleri multicancer early detection blood test ahead of a scheduled advisory committee meeting. The FDA advisory committee meeting regarding the Galleri test is set to take place on Wednesday.

Galleri is a prescription, qualitative in vitro diagnostic test from Grail intended to screen for early detection of multiple types of cancer in adults ages 50 and older. Members of the molecular and clinical genetics panel of the FDA's Medical Devices Advisory Committee will vote on whether there is reasonable assurance that Galleri is safe for use in patients who meet criteria specified in the proposed indication.

FDA staff stated that most cancer deaths expected to occur in the U.S. result from cancer types for which there are no guideline-recommended screening programs. "Blood-based multicancer detection tests offer the potential to detect multiple types of cancer through a single blood draw," agency staff members wrote in a published report.

"Screening tests, such as Galleri, that detect cancers for which there are no guideline-recommended screening options may provide detection of cancers that would otherwise go undetected, thereby helping to address an unmet medical need," FDA staff members said. However, agency staff members noted that risks associated with false positive and false negative results of a blood-based screening test should be carefully considered.

The NHS-Galleri study was a prospective, randomized controlled trial in which participants ages 50-77 with no clinical suspicion of cancer were enrolled to assess the performance of the Galleri MCED test for population screening in the U.K. when added to standard of care. Data from NHS-Galleri presented at the American Society of Clinical Oncology annual meeting in May 2024 showed the study failed to meet its primary outcome of reducing the number of cancers detected at stage III or IV across a dozen tumor types for which no screening tests are currently available.

The NHS-Galleri study detected more stage I and II cancers. The FDA briefing document did not review the endpoint of reducing stage III or IV cancers. Instead, the FDA briefing document focused on test performance and safety results from participants with 1 year of follow-up in PATHFINDER 2.

The FDA briefing document also focused on data from participants in the intervention arm of the prevalent screening round (first year) of the NHS-Galleri trial. Results from PATHFINDER 2 showed Galleri had a 12-month episode sensitivity of 35.0%. Results from PATHFINDER 2 showed Galleri had a negative predictive value (NPV) of 99.07%.

Results from PATHFINDER 2 showed Galleri had a cancer signal origin (CSO) prediction accuracy of 94.3%. In NHS-Galleri, the test demonstrated a 12-month episode sensitivity of 31.6%. In NHS-Galleri, the test demonstrated a NPV of 98.89%.

In NHS-Galleri, the test demonstrated a CSO predictive accuracy of 91.9%. The FDA will ask the panel for advice on appropriate labeling for Galleri, including warnings and other risk mitigation strategies. The FDA will also ask the panel for advice on how performance and limitations of the test should be communicated to healthcare providers and patients.

The INFORM study assesses the use of the Galleri test, which looks for small pieces of genetic material called deoxyribonucleic acid (DNA) in the blood that may indicate the presence of cancer. The Galleri test is already available as a laboratory-based diagnostic. FDA approval of the Galleri test would be expected to help lead to reimbursement from Medicare and other insurance payors.

Why It Matters

FDA staff identified that most cancer deaths in the U.S. stem from types lacking guideline-recommended screening programs, suggesting tests like Galleri could address an unmet medical need. Approval would likely facilitate reimbursement from Medicare and other insurers, expanding access to the diagnostic tool.

The advisory panel's votes on safety, efficacy, and risk-benefit balance will guide the FDA's final decision, though the agency is not bound by the recommendation. The panel will also advise on labeling and communication strategies to manage risks associated with false positives and negatives.

Timeline

On June 11, 2026, the U.S. Commission on Civil Rights published a notice in the Federal Register concerning the cancellation of a public briefing by the Montana Advisory Committee.

What's New

Additional reporting indicates the INFORM study is a prospective, interventional, single-group study evaluating the GRAIL Galleri multi-cancer early detection (MCED) test in participants considered at slightly higher than average risk of developing certain types of cancers.

PATHFINDER is a 1982 video game.

How Sources Differ

Sources differ on the specific design focus of studies involving GRAIL Galleri. Clinicaltrials describes the INFORM study as a prospective, interventional, single-group study evaluating the test in participants at slightly higher than average risk. The FDA briefing document states that PATHFINDER 2 was designed to evaluate the safety of Galleri in terms of diagnostic testing triggered by the MCED test result and to assess performance in individuals eligible for cancer screening.