GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Intermountain Healthcare today announced that Galleri^®, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, will be offered as a complement to existing single cancer screenings to help advance the delivery of cancer care through early detection. Starting this month, Intermountain will offer the Galleri test to eligible health system patients at elevated risk for cancer, such as adults over 50 years old or with additional risk factors. In addition, the test will be available to eligible employees and their families who are enrolled in a company-sponsored health plan.

“When it comes to cancer, we promote proactive measures through preventive screening wherever possible because it leads to better outcomes,” said Dr. Naresh Agarwal, associate chief medical officer for primary care at Intermountain Healthcare. “The continuing partnership with GRAIL provides us with additional resources to detect cancer in its early, more treatable stages, directly aligning with our commitment to help people live the healthiest lives possible.”

Early detection is known to improve cancer outcomes, yet, today, most cancer is detected too late because only five cancer types have recommended screenings – breast, cervical, colon, lung and prostate cancers. The Galleri test is the first-of-its-kind multi-cancer early detection blood test available. Using advanced genomics and machine learning, in a clinical study, the Galleri test was able to detect signals across more than 50 types of cancer, more than 45 of which lack recommended screening tests, with a low false positive rate of less than 1%. The test also can determine where in the body the cancer signal comes from with high accuracy.

Intermountain, the largest private employer in Utah, is a not-for-profit health system with 33 hospitals and more than 3,800 physicians. The system serves residents with hospitals and clinics in seven states and additional operations across the western United States.

“We are pleased to be expanding our partnership with Intermountain, a recognized leader in healthcare innovation, to expand its cancer screening capabilities with MCED," said Josh Ofman, MD, MSHS, president and chief medical officer at GRAIL. “Intermountain is a partner in the interventional PATHFINDER study evaluating the implementation and performance of the Galleri test in a clinical care setting and we’re grateful for their ongoing commitment to continuing to build the body of clinical evidence for the Galleri test. We applaud Intermountain’s forward-thinking approach to patient care so that, together, we can make progress against this devastating disease.”

Initial results from PATHFINDER were presented at the 2021 American Society of Clinical Oncology (ASCO), demonstrating that the performance of the Galleri test was consistent with findings from previous observational studies and underscoring the potential real-world ability of the Galleri test to find deadly cancers earlier. Final results from PATHFINDER will be presented at a medical meeting later this year.

About Intermountain Healthcare

Based in Utah with locations in seven states and additional operations across the western U.S., Intermountain Healthcare is a nonprofit system of 33 hospitals, 385 clinics, medical groups with some 3,800 employed physicians and advanced practice providers, a health plans division called SelectHealth with more than 1 million members, and other health services. Helping people live the healthiest lives possible, Intermountain is committed to improving community health and is widely recognized as a leader in transforming healthcare by using evidence-based best practices to consistently deliver high-quality outcomes at sustainable costs.

About Galleri^®

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older.

For more information about Galleri, visit www.galleri.com.

About GRAIL

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 wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.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.

Laboratory/Test Information

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.

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"We are pleased to be expanding our partnership with Intermountain, a recognized leader in healthcare innovation, to expand its cancer screening capabilities with MCED," said Josh Ofman, MD, MSHS, president and chief medical officer at GRAIL.