Grail reported it collected positive initial findings from the latest large study of its multi-cancer early detection test, Galleri, with data the company said it will submit to the FDA as it seeks a full marketing approval.
The top-line results from the Pathfinder 2 registrational study included more than 25,500 participants, recruited from the population that Grail hopes will one day be screened regularly with its blood test—namely, adults over the age of 50 who have no symptoms and no clinical suspicion of having cancer.
The study, first launched in 2021, examined the safety and accuracy of Galleri’s DNA-based approach to detecting as many as 50 cancers when added alongside standard cancer screening regimens such as colonoscopies or CT scans that search for one type of tumor at a time.
While the previous Pathfinder study—a prospective, yearlong examination of about 6,600 people—showed that Galleri could more than double the overall number of cancers found during screening, Grail said the trial’s sequel “demonstrated substantially greater additional cancer detection.”
The company also said that after 12 months, Pathfinder 2 was able to improve upon Galleri’s previously reported positive predictive value of 43%, though it did not list a figure.
In addition, the first Pathfinder study posted a specificity of 99.5% as well as 88% accuracy in the blood test’s ability to trace a cancer signal back to its originating organ site; Grail said Galleri performed similarly in those respects in Pathfinder 2.
Full details of the study—set to evaluate a total of 35,000 people—are expected to be presented at an international oncology meeting later this year, the company said in a statement.
Grail plans to include the Pathfinder 2 data in an FDA application for an updated version of the Galleri test, alongside results from a separate study being conducted with the U.K. National Health Service that spans more than 140,000 volunteers and aims to reduce the number of late-stage cancer diagnoses by hopefully catching them earlier. Results from the NHS-Galleri trial are expected in 2026.
The company said Galleri’s modular submission is currently underway at the FDA, thanks to a previous breakthrough designation, and that it is aiming to complete its application in the first half of next year.