Mayo Clinic today recognized the debut of a groundbreaking multi-cancer early cancer detection (MCED) test called Galleri™ that can detect more than 50 types of cancers^[1] through a simple blood draw. The Galleri test is intended  to complement U.S. guideline-recommended cancer screenings.

Mayo Clinic Oncologist Minetta Liu, M.D. was involved in the development of the new test.

“Today, many cancers are found too late, leading to poor outcomes,” says Dr. Liu. “The ability to detect cancer early is critical to successful treatment.”

Cancer is expected to become the leading cause of death in the U.S. this year. Currently recommended cancer screening tests only cover five cancer types and screen for a single cancer at a time. In fact, there are no recommended early detection screening tests for other cancers, which account for 71% of cancer deaths.

Researchers used the Galleri test in the Circulating Cell-free Genome Atlas (CCGA) Study, a prospective, observational, longitudinal study designed to characterize the landscape of genomic cancer signals in the blood of people with and without cancer. In the study, the Galleri test demonstrated the ability to detect more than 50 types of cancers — over 45 of which have no recommended screening tests today — with a low false-positive rate of less than 1%.

According to Dr. Liu, when a cancer signal is detected, the Galleri test can identify where in the body the cancer is located with high accuracy — a critical component to help enable health care providers to direct diagnostic next steps and care.

“We are grateful to Mayo Clinic for its dedication to advancing new technologies for early cancer detection and for playing a pivotal role in the development of Galleri,” says Dr. Josh Ofman, chief medical officer and head of external affairs at GRAIL.“A simple blood test capable of detecting more than 50 cancers is a ground-breaking advancement and could have a tremendous human and economic benefit.”

Initial results from the interventional PATHFINDER Study, which involved the return of Galleri test results to providers to communicate to participants, were presented today at the 2021 American Society of Clinical Oncology Annual Meeting. They demonstrate Galleri’s performance in the clinical setting was consistent with findings from previous observational studies, underscoring the potential real-world ability of Galleri to find deadly cancers earlier.

The Galleri test is for those at an elevated risk of cancer, such as adults age 50 or older and is available by prescription only.

Dr. Liu is the co-director of the Genomics in Action Program within the Mayo Clinic Center for Individualized Medicine, research chair of the Department of Oncology, and a consultant in the Department of Laboratory Medicine and Pathology. Dr. Liu conducts patient-oriented research focused on developing clinically relevant molecular markers to allow for the most accurate prediction of treatment benefit and patient outcomes in solid tumor malignancies. She also researches multi-cancer early cancer detection through blood assays and develops novel therapeutics to improve survival in early-stage and metastatic breast cancer.

^[1] Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV, Liu MC, Oxnard GR, Klein EA, Smith D, Richards D, Yeatman TJ. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020;31(6):745-59.

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