GRAIL PATHFINDER 2 Results Show Galleri® Multi-Cancer Early Detection Blood Test Increased Cancer Detection More Than Seven-Fold When Added to USPSTF A and B Recommended Screenings (GRAIL)

Results from GRAIL’s registrational PATHFINDER 2 study, presented at ESMO 2025, show that adding the Galleri multi-cancer early detection (MCED) blood test to standard screenings increased cancer detection rates more than seven-fold. Over half of Galleri-detected cancers were found at early stages, when treatment is most effective, and nearly three-quarters of cases were in cancers without current screening options. The test demonstrated high accuracy in identifying cancer signal origin, enabling faster and more efficient diagnostic workups, with a false positive rate of only 0.4%. With FDA submission underway, Galleri positions itself as a potential game-changer in how we approach population-level cancer screening.