\u2013The PATHFINDER Study will Return GRAIL\u2019s Test Results to Providers for the First Time \u2014<\/i><\/p>\n
\u2014 First Participants Successfully Enrolled \u2014<\/i><\/p>\n
\u2014 FDA Approves IDE for GRAIL\u2019s Test \u2014<\/i><\/p>\n
MENLO PARK, Calif., February 18, 2020 \u2013 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, today announced the initiation of the PATHFINDER Study. A prospective, multi-center study, PATHFINDER marks the first time GRAIL\u2019s test results will be returned to healthcare providers and communicated to participants to help guide appropriate diagnostic workup for more than 50 cancer types.<\/p>\n
Initial PATHFINDER health system partners include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health with plans to expand to additional partners. The first participants have been successfully enrolled.<\/p>\n
Today, the majority of deadly cancers do not have U.S. guideline-recommended screening paradigms, and as a result, many cancers are not detected until they have progressed to late stages when chances of survival are lower. Data from previous clinical studies demonstrate GRAIL\u2019s multi-cancer early detection test is able to detect more than 50 cancer types across all stages, with a very low false positive rate of less than one percent, through a single blood draw. When a cancer signal is detected, GRAIL\u2019s test is also able to identify where in the body the cancer is located with high accuracy. Identifying a cancer\u2019s tissue of origin will enable healthcare providers to efficiently guide PATHFINDER participants with a cancer \u201csignal-detected\u201d test result through the appropriate care pathway to arrive at a diagnostic resolution.<\/p>\n
\u201cGRAIL is at the forefront of transforming early cancer detection as we bring our multi-cancer test into clinical practice through our first interventional study,\u201d said Hans Bishop, Chief Executive Officer at GRAIL. \u201cWe are partnering with leading healthcare systems to gain important real-world insight into the clinical use of our multi-cancer early detection test, an important step on our path toward commercialization.\u201d<\/p>\n
\u201cGRAIL set out to develop a true multi-cancer early detection test, and we believe we have built the world\u2019s largest methylation database that\u2019s enabled machine learning rooted in fundamental insights into the biology of cancer signals in the blood,\u201d said Alex Aravanis, Chief Scientific Officer and Head of R&D, and a Founder of GRAIL. \u201cBuilding on our foundational investments in science and technology, we developed a high performing test for the detection of over 50 types of cancer, and we are excited to evaluate its ability to inform clinical care.\u201d<\/p>\n
The PATHFINDER Study is conducted under an investigational device exemption (IDE) to evaluate GRAIL\u2019s multi-cancer early detection test. GRAIL believes that its IDE application is the first approved by the Food and Drug Administration (FDA) for a return-of-results study involving a multi-cancer next-generation sequencing-based blood test.<\/p>\n
About the PATHFINDER Study<\/b><\/p>\n
The PATHFINDER Study is evaluating the implementation of GRAIL\u2019s investigational multi-cancer early detection test in clinical practice, and marks the first time GRAIL\u2019s test will be used to return results to people. PATHFINDER will enroll approximately 6,200 participants across several health systems and is sponsored by GRAIL. PATHFINDER is being conducted under an FDA approval of an IDE application for GRAIL\u2019s multi-cancer early detection blood test.<\/p>\n