I was excited today to present the initial results from the Pathfinder 2 study, which is a registrational interventional study examining the safety and efficacy of a multi-cancer early detection test or an MCED test in an intended use population. The Pathfinder 2 study is GRAIL’s second interventional MCED clinical trial in the U.S. The GRAIL Galleri Multi-Cancer Early Detection Test is a blood test that looks at circulating free DNA, particularly methylation patterns on that circulating free DNA that’s shed into the bloodstream to help to try to detect the cancer, utilizing next-generation sequencing and machine learning...
I was excited today to present the initial results from the Pathfinder 2 study, which is a registrational interventional study examining the safety and efficacy of a multi-cancer early detection test or an MCED test in an intended use population. The Pathfinder 2 study is GRAIL’s second interventional MCED clinical trial in the U.S. The GRAIL Galleri Multi-Cancer Early Detection Test is a blood test that looks at circulating free DNA, particularly methylation patterns on that circulating free DNA that’s shed into the bloodstream to help to try to detect the cancer, utilizing next-generation sequencing and machine learning. And if a cancer signal is detected, the test is also able to provide a cancer signal origin prediction to help the investigators kind of hone in on their diagnostic workup. The purpose of the Galleri multi-cancer early detection test is to be used as a population-level pan-cancer screening test. So the Pathfinder 2 study builds upon the original Pathfinder study and that it’s an interventional single-arm multi-cancer detection prospective study where we enrolled nearly 36,000 participants, over 32 North American healthcare systems, over 32 months. Inclusion criteria on the clinical trial were participants age 50 and older, no clinical suspicion of cancer, and no cancer history within the last three years. Participants were provided with a blood test, the MCED test was performed, the results were returned to the participant. And for those with a positive MCED test result, diagnostic workup based on the cancer signal origin prediction was underway by the provider. The study is following patients for a total of three years to assess cancer status and participant-related outcomes, such as adherence to recommended screening guidelines. And the primary endpoint of the Pathfinder 2 study is to assess the safety and efficacy of the test in an intended use population. The findings of the Pathfinder 2 study identified a cancer signal detection rate of about 1%. And for those participants that had a positive MCED test result, the positive predictive value or the probability of the test being truly positive was 62%, meaning that six out of 10 participants with a positive test result ultimately were found to have cancer. Furthermore, the MCED test detected cancers seven-fold more than standard of care cancer screening.
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