Cleveland Clinic Joins Interventional Study Using GRAIL’s Multi-Cancer Early Detection Test to Help Guide Clinical Care

Cancer detection company GRAIL has announced that Cleveland Clinic has joined GRAIL’s PATHFINDER Study, a prospective, multi-cancer clinical study that is evaluating the implementation of Galleri™, an investigational multi-cancer early detection blood test, into clinical practice for the first time.

Today, most 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 only cover four cancers and screen for a single cancer at a time. In fact, cancers responsible for nearly 71 percent 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 GRAIL Chief Medical Officer and External Affairs Joshua Ofman, MD. “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 the Circulating Cell-free Genome Atlas (CCGA) study conducted by GRAIL demonstrated that an earlier version of Galleri could detect more than 50 cancers across all stages—over 45 of which do not have early cancer screening today—with a very low false positive rate of less than 1 percent, 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 be effectively implemented in clinical practice.

Cleveland clinic joins initial PATHFINDER health systems 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 to evaluate Galleri. 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.

Read the original press release here.