“MCED tests have the potential to expand the number of cancers detected with a low false-positive rate when added to recommended single-cancer screenings. “The PATHFINDER study provides crucial insights into how MCED testing can be used in clinical settings and demonstrates its additive benefit for cancer screening in clinical practice for eligible patients,” said Jeffrey Venstrom, MD, chief medical officer at GRAIL. Standard screenings identified 29 cancers. Of those who received a cancer signal detected result, 36 cancers were diagnosed in 35 participants (one participant was diagnosed with two cancers). Preventive Services Task Force (USPSTF) standard of care screening, GRAIL’s MCED test more than doubled the number of cancers detected compared to standard screening alone. Study results showed that the GRAIL test cancer signal origin (CSO) prediction was 97% accurate and directed the clinical workup, leading to resolution of the cancer diagnosis in less than three months (median 79 days) among participants who received a cancer signal detected result. outpatient settings to determine the time required and diagnostic testing necessary to reach a diagnostic resolution following a cancer signal detected test result (primary endpoint). The prospective cohort assessed use of GRAIL’s targeted methylation-based MCED test with 6,662 enrolled participants in U.S. This study demonstrates the feasibility of screening for multiple cancers using a blood test and lays the foundation for large, controlled trials necessary to establish clinical utility and cost-effectiveness." In the vast majority of cases, the test accurately predicted the type of cancer. The screening test identified a cancer signal in 1.4% of participants, 0.5% of whom were confirmed to have cancer. "The PATHFINDER study was a pilot non-randomized study to evaluate how patients and clinicians would respond to a blood test to screen for multiple cancer types. "The possibility of screening for multiple types of cancer simultaneously using a blood specimen is promising both because there are no effective screening strategies for many types of cancer and because strategies with established effectiveness require considerable time and effort," noted Deb Schrag, MD, MPH, Chair, Department of Medicine at Memorial Sloan Kettering in New York and a PATHFINDER investigator. The study, conducted in 6,662 adults over the age of 50 without symptoms suggestive of cancer, demonstrated that an earlier version of GRAIL’s MCED test identified many cancer types that do not currently have recommended screening tests, enabled targeted cancer diagnostic evaluations, and supported diagnostic resolution for the majority of participants in less than three months. MENLO PARK, Calif.-( BUSINESS WIRE)-GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced that detailed findings from the PATHFINDER study of its multi-cancer early detection (MCED) blood test have been published in The Lancet.
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