UH First Health System in Northeast Ohio to Widely Offer Galleri®, a Multi-cancer Early Detection Blood Test Designed to Screen for More Than 50 Types of Cancer

CLEVELAND – In the United States, one in two men and one and three women will be diagnosed with cancer in their lifetime. And many will be diagnosed in later stages when it is more difficult to treat. That’s why healthcare providers at University Hospitals (UH) Seidman Cancer Center are looking to the next frontier in cancer detection by offering the Galleri^® test.

“Everyone knows someone who has been impacted by cancer, and too many of us have lost someone to this devastating disease,” said Dr. Jordan Winter, Director of Surgical Services at UH Seidman Cancer Center, the John and Peggy Garson Family Endowed Chair in Pancreatic Cancer Research and the Jerome A. and Joy Weinberger Family Master Clinician in Surgical Oncology. “We are thrilled to be able to offer Galleri to eligible members of our community. This test can screen for multiple types of cancer, including many without recommended screenings, potentially helping to detect a cancer signal before symptoms appear and the cancer has spread.”

The Galleri test is a first-of-its-kind MCED blood test. In a clinical study, the Galleri test demonstrated the ability to detect a signal shared by more than 50 types of cancer, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also predicts the tissue or organ associated with the cancer signal, which can help guide diagnostic evaluation. Galleri is intended for people with an elevated risk of cancer, such as those aged 50 or older, and is to be used in addition to recommended cancer screenings.

“Single-cancer screenings play an important role in detecting five specific cancers today. However, the status quo for cancer screening remains unacceptable with nearly 70% of deaths caused by cancers that don’t have recommended screenings. When used as recommended, in addition to current single-cancer screenings, the Galleri test is a promising tool that can help screen for some of the deadliest cancers that often come with no warning today like pancreatic, esophageal, ovarian, and liver,” said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. “We applaud forward-thinking health systems like University Hospitals for sharing in our commitment to bring forth innovative screening technologies to help bend the cancer mortality curve.”

First responders experience an elevated risk. In a National Institute for Occupational Safety and Health (NIOSH) study, firefighters had a 9% increase in cancer diagnoses and a 14% increase in cancer related deaths compared to the number of cancers expected using U.S. population rates.

More than 610,000 people are expected to die from cancer each year in the United States, according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate and (in high-risk adults) lung. In fact, about 70% of cancer deaths are from cancers that lack recommended screening. At University Hospitals Seidman Cancer Center, positive Galleri tests may be referred to the Diagnostic Clinic at 216-286-2626 for further evaluation and workup if needed.

Important Galleri Safety Information

The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment.

Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of  Cancer Signal Detected does not rule out cancer. A test result of      Cancer Signal Detected requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer.

If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.

Laboratory/Test Information

The GRAIL clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.