MENLO PARK, Calif. and ST. LOUIS – Mercy and GRAIL, LLC, a health care company whose mission is to detect cancer early when it can be cured, today announced plans to offer a multi-cancer early detection (MCED) blood test. GRAIL’s Galleri® test uses advanced testing capabilities to detect early cancer signals of more than 50 types of cancer. Mercy is early among health systems to offer this first-of-its-kind test.
“Recommended cancer screenings in the U.S. currently cover only five types of cancer – breast, cervical, colon, lung and prostate – and can screen just one at a time,” said Dr. Jay Carlson, clinical chair of Mercy Research, gynecologic oncologist and head of Mercy’s cancer specialty council. “This innovative test has shown the ability to screen for hard-to-detect, aggressive and often deadly types of cancer like pancreatic, ovarian and esophageal, which oftentimes have no warning signs and are caught too late.”
The MCED test, which is intended to complement U.S. guideline-recommended cancer screenings, looks for a shared signal present in the bloodstream that has been associated with many cancers.
“Early detection can play a critical role in cancer treatment, allowing cancers to be caught when treatment is more likely to be successful,” said Bob Ragusa, chief executive officer at GRAIL. “We believe new approaches, including multi-cancer early detection tests, are the new front in the war on cancer and one of our best chances to bend the cancer mortality curve. We’re excited to work with Mercy to offer Galleri to their patients.”
The MCED test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. Galleri is available by prescription only and use of the test is not recommended for those who are pregnant, 21 years or younger, or undergoing active cancer treatment. Patients interested in the test can visit mercy.net/EarlyCancerDetection to fill out a form and, if eligible, be contacted by a Mercy care navigator to walk them through the ordering and testing process. Results will be delivered through care navigators approximately two weeks after blood is drawn and, if a positive signal is detected, they will coordinate additional testing and care.
One of the first Mercy patients to schedule the test was Nancy Dixon, a Mercy co-worker in Oklahoma City.
“My dad died when he was 51 from pancreatic cancer, one of the worst cancers because once you know you have it, the cancer is too far gone,” Dixon said. “It’s always been a lingering fear. I was 16 then; I’m now 55. This test gives me some peace of mind rather than not knowing and just waiting. I wish my dad had been able to have access to this blood test. He might be alive today and know my daughter, his grandchild.”
In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, over 45 of which lack recommended screen tests today. Because the blood test is not currently covered by insurance, patients will pay out of pocket. Mercy will work with patients who qualify for but are unable to pay the total cost of the test.
“Technology continues to push the boundaries on what we are able to do in medicine, making it more predictive, proactive and personalized for patients,” said Dr. John Mohart, Mercy chief clinical officer and communities president, who leads operations for all Mercy hospitals. “Early detection has the potential to give us more years with our loved ones, and that’s invaluable.”
Mercy, one of the 25 largest U.S. health systems, serves millions annually with nationally recognized quality care and one of the nation’s largest Accountable Care Organizations. Mercy is a highly integrated, multi-state health care system including more than 40 acute care, managed and specialty (heart, children’s, orthopedic and rehab) hospitals, convenient and urgent care locations, imaging centers and pharmacies. Mercy has 900 physician practices and outpatient facilities, 3,400 Mercy Clinic physicians and advanced practitioners, and more than 40,000 co-workers serving patients and families across Arkansas, Kansas, Missouri and Oklahoma. Mercy also has clinics, outpatient services and outreach ministries in Arkansas, Louisiana, Mississippi and Texas.
GRAIL is a healthcare company whose mission is to detect cancer early when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021.
For more information, please visit grail.com.
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 Not 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.
GRAIL’s 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. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.