GRAIL, Inc. (GRAL), a healthcare company, presented positive performance and safety results from its PATHFINDER 2 study evaluating the Galleri multi-cancer early detection (MCED) test during an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
The Galleri multi-cancer early detection (MCED) test is designed to screen more than 50 cancer types, including pancreatic, ovarian and liver/bile duct cancers. It is currently available in the U.S. as a laboratory-developed test performed in a Clinical Laboratory Improvement Amendments (CLIA)- certified lab.
Trial Details
PATHFINDER 2 is a prospective, multi-centre, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States.
PATHFINDER 2 is the largest interventional study of a multi-cancer early detection (MCED) test in North America to date, enrolling 35,878 participants in the U.S. and Canada, the company said.
Key Findings
In PATHFINDER 2, 60% of diagnosed cancers were screen-detected.
The PATHFINDER 2 study demonstrated that the test identified the Cancer Signal Origin (CSO) 91.3% of the time, leading to efficient diagnostic workups.
Following a positive MCED test result, only 0.6% of all safety-analyzable participants had an invasive procedure, and Diagnostic resolution took a median of 48 days, the firm noted.
In addition, a 6.5-fold increase in the number of cancers detected by screening was observed when the Galleri MCED test was added to recommended screenings for breast, cervical, colorectal, and lung cancers.
Screening with the Galleri test had a favourable safety profile, with a low false-positive rate and a low rate of invasive procedures.
Galleri detected nearly three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers.
In the first quarter of 2026, GRAIL's total revenue increased 28% year-over-year to $40.78 million, from $31.84 million in the prior year.
Net loss for the first quarter narrowed to $93.19 million, or $2.29 per share, from $106.21 million or $3.10 per share, in the prior year.
GRAL has traded between $29.95 and $118.84 over the last year. The stock closed Friday's trade at $71.68, down 3.30%.
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