PR Newswire·May 31, 2026, 8:00 AM ET

GRAIL Presents PATHFINDER 2 Results of More Than 35,000 Participants Showing the Galleri® Test Substantially Increased Cancer Detection With Robust Performance and Favorable Safety at 2026 ASCO Annual Meeting

GRAIL presented full PATHFINDER 2 study results involving 35,878 participants aged 50+ at the 2026 ASCO Annual Meeting.
Adding the Galleri MCED test to recommended screenings for breast, colorectal, cervical, & lung cancers increased cancer detection by 6.5-fold.
71.3% of new cancers detected by Galleri were at stages I-III, with 53.0% at stage I or II.
71% of cancers found by Galleri were in types lacking USPSTF A or B recommended screenings.
The test showed a positive predictive value (PPV) of 60.3% for cancer diagnosis following a positive signal.
Episode sensitivity was 69.8% for the 12 deadliest cancers & 39.3% for all cancers within 12 months.
Specificity was 99.6%, resulting in a false positive rate of less than 0.4%.
The test correctly identified the Cancer Signal Origin (CSO) 91.3% of the time to guide diagnostic workups.
Median diagnostic resolution time was 48 days, with only 0.6% of participants undergoing invasive procedures.
90.5% of invasive procedures were nonsurgical, & five study-related adverse events were reported only in participants with confirmed cancer.
GRAIL noted that Galleri is not FDA-cleared but is a CLIA-certified lab test intended for adults at elevated cancer risk.