FDA panel recommends benefits of Grail Galleri test

GRAIL, Inc. is undergoing a regulatory review by an FDA advisory panel regarding its Galleri multi-cancer early detection blood test. The test, intended for adults aged 50 and older, identifies DNA fragments shed by tumor cells to detect multiple types of cancer.

While FDA reviewers have reported no major outstanding concerns regarding primary safety analysis, they have tasked the Molecular and Clinical Genetics Panel with evaluating whether clinical performance data justifies the company’s proposed labeling for ‘early’ cancer detection. The panel must determine if the test’s benefits outweigh risks such as missed diagnoses or false alarms.

Data from the PATHFINDER 2 study indicated a specificity of 99.64% and a positive predictive value of 60.3%. Among those with newly diagnosed primary cancers, 53% were in stage 1 or 2, and the test correctly predicted the cancer’s likely origin in 91.3% of cases.

On September 23, 2026, the FDA’s Molecular and Clinical Genetics Devices Committee issued a recommendation stating that the benefits of the Galleri test outweigh its risks for the target population. The committee voted 7-2, with one abstention, in favor of the test’s benefit-risk profile. While the panel reached a unanimous decision regarding safety, votes on the test’s effectiveness were more divided, resulting in a 6-4 split.

Although the panel’s recommendation is nonbinding, it marks a significant milestone toward potential FDA approval. Such approval could facilitate coverage through Medicare and private insurers, moving the test beyond its current status of being primarily available via out-of-pocket payments. Medical experts noted that while the technology is promising, further research is required to address concerns regarding false positives and the clinical value of investigating detected signals.