On August 6, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported that Cleveland Clinic has joined GRAIL’s PATHFINDER Study, a prospective, multi-center clinical study that is evaluating the implementation of Galleri, an investigational multi-cancer early detection blood test, into clinical practice for the first time (Press release, Grail, AUG 6, 2020, View Source [SID1234563179]).
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Today, the majority of cancers are found too late when outcomes are often fatal, because most deadly cancers have no available screening tests. Current recommended screenings are critical, but they cover only four cancers and screen for a single cancer at a time. In fact, cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening.
"We believe multi-cancer early detection has the potential to address a tremendous unmet need and reduce the cancer burden worldwide," said Joshua Ofman, MD, MSHS, Chief Medical Officer and External Affairs at GRAIL. "We are honored to partner with Cleveland Clinic and our other PATHFINDER Study partners in this endeavor, and are grateful to all the participants across the U.S. who are helping to bring this potentially transformative technology to patients, providers, and communities."
Data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) Study demonstrated an earlier version of Galleri could detect more than 50 cancers across all stages — over 45 of which don’t have early cancer screening today — with a very low false positive rate of less than 1%, through a single blood draw. The PATHFINDER Study is an important step on the path to commercialization by allowing GRAIL to evaluate how Galleri can effectively be implemented in clinical practice.
Cleveland Clinic joins initial PATHFINDER health system partners that include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health.
The PATHFINDER Study is conducted under an investigational device exemption (IDE) application approved by the Food and Drug Administration (FDA) to evaluate GRAIL’s multi-cancer early detection test. GRAIL believes that its IDE application is the first approved by the FDA for a return-of-results study involving a multi-cancer next-generation sequencing-based blood test.
About the PATHFINDER Study
The PATHFINDER Study is evaluating the implementation of GRAIL’s investigational multi-cancer early detection test in clinical practice, and marks the first time Galleri will be used to return results to people. PATHFINDER will enroll approximately 6,200 participants across several health systems and is sponsored by GRAIL.
GRAIL’s test is not yet available for use outside of this investigational study. It is not meant to replace the cancer screening tests healthcare providers may recommend, such as colonoscopy or mammography. For more information, visit www.grail.com/clinical-studies/pathfinder-study.