Caris Life Sciences vs GRAIL

Caris holds an FDA PMA approval (P240010, MI Cancer Seek, November 2024), while the Galleri site says Galleri has not been cleared or approved by FDA. GRAIL filed its PMA in full on January 29, 2026, and on September 23, 2026 an FDA panel voted 7 yes, 2 no and 1 abstention that benefits outweigh risks, with effectiveness at 6 yes and 4 no. The NHS-Galleri trial missed its primary endpoint, and BMJ ran that headline in 2026.

Galleri is a CLIA-lab blood test for adults 50 and older, so a primary care group weighing multi-cancer screening is its buyer. The Caris homepage lists Caris Detect as a multi-cancer blood test and gives no FDA status for it, which makes Detect the Caris product that faces Galleri. A primary care group choosing between the two picks Galleri on the stated facts, a pending PMA and published trial data against a homepage listing. A cancer center sending a tumor biopsy for profiling is a different customer and uses MI Cancer Seek.