On Oct. 18, 2025, GRAIL announced that positive performance and safety results from its registrational PATHFINDER 2 study are being presented at the European Society for Medical Oncology (ESMO) Congress 2025.

PATHFINDER 2 evaluated the safety and performance of the Galleri^® multi-cancer early detection (MCED) test when used alongside standard-of-care cancer screenings. The largest interventional study of an MCED test in the United States to date, the prospective PATHFINDER 2 study includes 35,878 enrolled participants across the United States and Canada in a broad, intended-use population of adults aged 50 and older with no clinical suspicion of cancer.

Results were presented from a pre-specified analysis of the first 25,578 participants with at least 12 months of follow-up as of Dec. 31, 2024. Of these, 23,161 were analyzable for performance and 25,114 were analyzable for safety.

Data from the performance analyzable cohort of 23,161 participants with 12 months of follow-up found that adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year.

Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations). Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options. More than half (53.5%) of the new cancers detected by Galleri were stage I or II and more than two-thirds (69.3%) were detected at stages I-III.