A U.S. Food and Drug Administration advisory panel voted 7-2, with one abstention, that the benefits of Grail's Galleri multi-cancer early-detection test outweigh its risks for adults aged 50 and older. The Molecular and Clinical Genetics Devices Panel voted unanimously that the test is safe and supported its clinical effectiveness by 6-4. Galleri analyzes blood for cancer-linked methylation signatures before symptoms emerge, then estimates the likely cancer origin after identifying a signal. It is intended to supplement, rather than replace, established cancer screening. Grail says randomized controlled studies including PATHFINDER 2 and NHS-Galleri found Galleri detected roughly four to seven times more cancers than standard care alone, with many cases found at early stages and low false-positive rates. The FDA granted the test Breakthrough Device designation in 2018 and is not required to follow the panel's recommendation. Shares rose 8.03% to $117.23 on Thursday, near their 52-week high of $118.84.