Grail has reported encouraging top-line performance and safety outcomes from its registrational PATHFINDER 2 study鈥檚 pre-specified analysis of the Galleri multi-cancer early detection (MCED) test.
The analysis of the first 25,578 subjects showed a substantial increase in cancer detection compared to the earlier PATHFINDER study, where Galleri doubled the number of identified cancers.
The PATHFINDER 2 study is a multi-centre, prospective, interventional trial, with primary objectives focusing on the effectiveness, safety, and various performance measures of the Galleri test.
It began in 2021 to assess the test’s performance and safety when used with the standard of care single cancer screening in over 35,000 adults aged more than 50 years with no apparent signs of cancer.
With a 12-month follow-up, data from the PATHFINDER 2 revealed a higher positive predictive value (PPV) than the earlier study, with consistent specificity and cancer signal origin (CSO) accuracy.
The outcomes of PATHFINDER 2 are set to be submitted to the US Food and Drug Administration (FDA) as part of the premarket approval application (PMA) for the test, alongside data from the NHS-Galleri trial.
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By GlobalDataGrail will also provide bridging analyses for comparing the Galleri test versions used in both studies with the updated version planned for FDA submission.
The company is currently engaged in a modular submission process with the US regulator for Galleri, which has been awarded a breakthrough device designation.
The company anticipates completing this submission by the first half of 2026.
Grail president Josh Ofman said: 鈥淲e are delighted to see the 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鈥檚 prevalent screening round.
鈥淲e look forward to sharing the detailed PATHFINDER 2 data at a medical congress later this year.鈥�
In February 2025, Grail partnered with Quest Diagnostics to enable access to its Galleri test for healthcare providers in the US.
