# FDA panel recommends benefits of Grail Galleri test > Live situation record from CLSTR: https://clstr.news/situations/20260923-fda-review-of-grail-galleri-cancer-blood-test > Updated: 2026-09-23T13:22:20.000Z. Sources: 26. Developments: 2. 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. ## Claims - The FDA advisory panel voted 7-2, with one abstention, that the benefits of the Galleri test outweigh its risks. (disputed by 12 sources) - The panel voted 10-0 that there is reasonable assurance the Galleri test is safe. (disputed by 10 sources) - The panel voted 6-4 that there is reasonable assurance of the test's effectiveness. (disputed by 10 sources) - The Galleri test is designed to screen adults aged 50 and older for multiple types of cancer using cell-free DNA methylation patterns. (corroborated by 9 sources) - The FDA is not legally bound by the advisory panel's recommendation and will make a final decision in the coming months. (corroborated by 8 sources) - Clinical studies indicate the test can detect more cancers than standard screening alone, often at earlier, more treatable stages. (corroborated by 2 sources) ## Timeline ### 2026-09-23: Grail's Galleri blood test receives favorable FDA advisory panel recommendation An FDA advisory panel has recommended approval for Grail Inc.’s Galleri blood test, which screens for multiple cancers in adults aged 50+, citing benefits that outweigh risks despite divided views on efficacy. 19 sources. https://clstr.news/cluster/grails-galleri-cancer-blood-test-undergoes-fda-advisory-review ### 2026-09-21: GRAIL faces FDA advisory panel review for Galleri cancer blood test An FDA advisory panel is reviewing GRAIL's Galleri blood test to determine if its benefits for early cancer detection outweigh risks for adults aged 50 and older. 11 sources. https://clstr.news/cluster/fda-advisory-panel-reviews-grails-galleri-cancer-blood-test --- Cite as: FDA panel recommends benefits of Grail Galleri test. CLSTR, https://clstr.news/situations/20260923-fda-review-of-grail-galleri-cancer-blood-test