Summary: GRAIL has completed enrollment for the PATHFINDER 2 and NHS-Galleri clinical trials, involving over 175,000 participants, to evaluate the Galleri multi-cancer early detection test.
Key Takeaways:
- Large-Scale Enrollment: PATHFINDER 2 enrolled over 35,000 participants in North America, and NHS-Galleri enrolled over 140,000 participants in England, ensuring diverse representation in the study populations.
- Comprehensive Evaluation: The trials aim to validate the safety, performance, and clinical utility of the Galleri MCED test, with results from the first 25,000 PATHFINDER 2 participants expected in the second half of 2025 and final NHS-Galleri results in 2026.
- FDA Approval Process: Data from these studies will support GRAIL’s premarket approval application to the FDA, which is in progress under a Breakthrough Device Designation, highlighting the potential impact of the Galleri test on early cancer detection.
GRAIL provided an update on the PATHFINDER 2 and NHS-Galleri registrational clinical trials evaluating the Galleri multi-cancer early detection (MCED) test.
GRAIL has completed the PATHFINDER 2 study’s planned enrollment of more than 35,000 participants who are eligible for guideline-recommended cancer screening at more than 30 healthcare institutions in North America. In addition, GRAIL has completed the third and final round of study visits for the NHS-Galleri trial, which enrolled more than 140,000 participants.
“The PATHFINDER 2 and NHS-Galleri studies will significantly expand our existing clinical validation and performance evidence for the Galleri test. By supplementing our robust clinical evidence program with more than 35,000 participants in the U.S. for PATHFINDER 2 and over 140,000 participants in England for NHS-Galleri, we will continue our generation of additional performance, safety, and clinical utility data,” says Bob Ragusa, CEO at GRAIL. “Both studies were designed to enroll a diverse participant population, representative of socio-economic, ethnicity, gender and age differences, and we are proud of the diversity of the study populations. The data from these studies, as well as supplemental data from our other clinical studies, will support our premarket approval application submission for Galleri to the FDA, which is currently in process with a modular submission under a Breakthrough Device Designation from the FDA. We look forward to seeing results from the first 25,000 individuals enrolled in the PATHFINDER 2 study in the second half of 2025 and final results from the NHS-Galleri trial in 2026.”
About the PATHFINDER 2 Study
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in a population of individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in the United States. PATHFINDER 2 is being conducted pursuant to an FDA-approved investigational device exemption (IDE) application and began enrolling in December 2021.
The primary objectives of the study are 1) to evaluate the safety and effectiveness of GRAIL’s MCED test based on the number and type of diagnostic evaluations performed in participants who receive a cancer signal detected test result, and 2) to evaluate the performance of GRAIL’s MCED test across various measures, including positive predictive value (PPV), negative predictive value (NPV), sensitivity, specificity, and cancer signal origin (CSO) prediction accuracy. Participants who receive a cancer signal detected result undergo additional diagnostic testing based on the predicted CSO to determine if a cancer is present. Secondary objectives include utilization of guideline-recommended cancer screening procedures after use of the MCED test, and participant reported outcomes (PRO) over several time points, including an assessment of participants’ anxiety and satisfaction with the MCED test. Timepoints for collection will include baseline measurement prior to testing, post-results, and post-diagnostic resolution for positive test results.
Further reading: Getlabs to Add GRAIL’s Multi-Cancer Early Detection Test for Home Diagnostic Services
The PATHFINDER 2 study is being conducted with leading healthcare institutions across the United States, including Cleveland Clinic, Duke University Health System, Flushing Hospital Medical Center, Henry Ford Health System, Hoag, Inova, Jamaica Hospital Medical Center, Kelsey-Seybold Clinic, Mayo Clinic, Morehouse School of Medicine, Ochsner Health, Oregon Health & Science University, Sarah Cannon, Sutter Health, University of Oklahoma, University of Pittsburgh, Virginia Commonwealth University, Weill Cornell Medicine, and others.
