2 Clarke Drive
Suite 100
Cranbury, NJ 08512
© 2025 MJH Life Sciences™ and OncLive - Clinical Oncology News, Cancer Expert Insights. All rights reserved.
Galleri, a multicancer early detection test, demonstrated high positive predictive value and cancer detection in PATHFINDER 2.
Galleri Multicancer Early Detection Test :
© Bipul Kumar - stock.adobe.com
The Galleri multicancer early detection (MCED) test produced positive performance and safety outcomes among patients over 50 years of age with no clinical suspicion of cancer when added to standard-of-care single cancer screening, according to topline data from a prespecified analysis of the registrational PATHFINDER 2 trial (NCT05155605).1
PATHFINDER 2 was initiated in 2021 and comprised 35,878 adult patients. The current analysis includes data from the first 25,578 participants included in the study.
Previously published findings from the prospective PATHFINDER study (NCT04241796) demonstrated that Galleri had a positive predictive value (PPV) of 43% (95% CI, 30.8%-55.9%), a specificity of 99.5% (95% CI, 99.3%-99.6%), and a cancer signal origin (CSO) accuracy of 88%.2 The study enrolled 3681 patients who were at least 50 years old with additional cancer risk.
With 12 months of follow-up, data from PATHFINDER 2 showed that the addition of Galleri to standard single cancer screening produced greater additional cancer detection than what was reported in PATHFINDER and there were no serious safety concerns.1 The PPV was substantially higher compared with data from PATHFINDER and the cancer signal origin accuracy and specificity were consistent between the 2 trials.
“We are delighted to see very encouraging performance of the Galleri MCED test as a cancer screening tool in broad intended use populations of asymptomatic adults over 50 years of age in both the PATHFINDER 2 study and the NHS-Galleri trial’s prevalent screening round,” Josh Ofman, MD, MSHS, president of GRAIL, stated in a news release. “We would like to extend our sincere gratitude to all of the participants and investigators in both of these pivotal studies, who are collectively helping to realize the potential of this groundbreaking technology for population-scale multi-cancer early detection and move the field forward.”
The Galleri test employs a simple blood draw that identifies circulating tumor DNA. The test can detect multiple cancer types, including pancreatic, esophageal, ovarian, and liver. Additionally, the test can screen for cancer before symptoms arise and can identify the disease origin.
PATHFINDER 2 was a prospective, multicenter interventional study that evaluated the Galleri MCED test in participants enrolled in North America.3 Participants needed to be at least 50 years old to be included in the study. The target age ranges of 60 to 69 years and 70 to 79 years were enriched to increase the number of cancer events during the trial. Diagnostic procedures based on the test-returned CSOs were performed when a cancer signal was detected.
The primary outcomes were test safety, PPV, negative predictive value, sensitivity, specificity, CSO accuracy, cancer detection rate, and the diagnosis of invasive cancer. Secondary outcomes included participant-reported anxiety, participant-reported intention to follow and use guideline-recommended cancer screening procedures, and cancer detection rate by confirmatory PET-CT in participants for whom CSO-directed workups did not result in a diagnosis of cancer.
Detailed results from PATHFINDER 2 will be submitted for presentation at an international oncology meeting before the end of 2025, according to GRAIL.1
These findings will also be submitted to the FDA as part of the premarket approval application (PMA) for Galleri with results from the prevalent screening round of the NHS-Galleri trial. Findings from bridging analyses will also be submitted to the FDA to compare the performance of the version of the test used in PATHFINDER 2 and NHS-Galleri with the updated version that will be submitted for the PMA.
The PMA is currently proceeding through modular submission under FDA breakthrough device designation. GRAIL expects to complete the PMA submission in the first half of 2026.
Related Content: