GRAIL LLC announces findings from multi-cancer detection blood test

GRAIL, LLC “announced that detailed findings from the PATHFINDER study of its multi-cancer early detection blood test have been published in The Lancet. 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. The prospective cohort assessed use of GRAIL’s targeted methylation-based MCED test with 6,662 enrolled participants in U.S. 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). Study results showed that the GRAIL test cancer signal origin prediction was 97% accurate and directed the clinical workup, leading to resolution of the cancer diagnosis in less than three months among participants who received a cancer signal detected result. In the study, when added to U.S. Preventive Services Task Force standard of care screening, GRAIL’s MCED test more than doubled the number of cancers detected compared to standard screening alone. Of those who received a cancer signal detected result, 36 cancers were diagnosed in 35 participants. Standard screenings identified 29 cancers. Among participants who received an MCED cancer signal detected result and had a confirmed new cancer diagnosis (true positives), nearly half (48%) were detected at an early stage (I-II) when the potential for curative treatment is increased. Importantly, 74% of the MCED-detected cancers were cancer types that do not currently have recommended screening tests. These included cancers of the bile duct, small intestine, pancreas and spindle cell neoplasm, all highly lethal cancers that may be amenable to surgical resection at early stages. GRAIL, LLC, is a subsidiary of Illumina, Inc. currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission.”