Providence and GRAIL Expand Partnership to Increase Access to Galleri® Multi-Cancer Early Detection Screening

Providence, a not-for-profit health system serving the Western U.S., and GRAIL, LLC, a healthcare company with a mission to detect cancer early when it can be cured, today announced the expansion of their partnership to offer multi-cancer early detection screening as part of clinical care to eligible individuals across the entire Providence health system.

Through the partnership, eligible patients at Providence’s 52 hospitals and 900 clinics across seven states will have access to GRAIL’s Galleri^® multi-cancer early detection (MCED) test, as part of a comprehensive range of health services. In clinical studies, Galleri has demonstrated the ability to detect signals across more than 50 types of cancers — more than 45 of which lack recommended screening tests today. When a cancer signal is detected, Galleri can help ascertain where in the body the cancer is located with high accuracy, all from a single blood draw. In addition to broadening access to MCED testing, the expansion supports innovative diagnostics and genomics research aimed at improving cancer screening and treatment.

“Providence is committed to collaborations that provide individuals with the best evidence-based care including advancements like early cancer screenings that can improve patient outcomes,” said Ora Karp Gordon, M.D., Regional Medical Director of Providence’s Clinical Genetics & Genomics Program. “As a complement to current cancer screening programs, we believe the novel Galleri test offers an innovative way to assist with early cancer detection, especially with patients at high risk for difficult to detect cancers.”

According to the American Cancer Society, more than 609,000 people are expected to die from cancer in 2023 in the U.S. This is in large part because some of the deadliest cancers are identified in later stages when outcomes are often poorer. Though cancer screening tests can lead to life-saving treatments, only five types of tests are available in the U.S.: breast, colon, cervical, prostate, and, in high-risk adults, lung. In fact, about 71% of cancer deaths are a result of cancers that lack early detection screening.

“One of the best ways to improve cancer outcomes is to find cancer earlier, when it is easier to treat and the likelihood of survival is higher,” said Jeffrey Venstrom, M.D., Chief Medical Officer at GRAIL. “We are thrilled to expand our partnership with innovative health systems like Providence to promote broader adoption of our MCED blood test within their expansive network. Ultimately our goal is to reduce the burden of cancer and continue to advance understanding of the disease.”

Providence was the first health system in the nation to offer the MCED blood test as a complement to recommended cancer screenings to advance the science and delivery of cancer care. Providence and GRAIL previously announced an initial partnership in March 2021 to offer Galleri at Providence’s California, Washington and Oregon points of care. With the expanded partnership, Galleri is now available to eligible patients through Providence in Alaska, Montana, New Mexico and Texas.

About Providence

Providence is a national, not-for-profit health system comprising a diverse family of organizations and driven by a belief that health is a human right. With 52 hospitals, over 900 physician clinics, senior services, supportive housing, and many other health and educational services, the health system and its partners employ more than 120,000 caregivers serving communities across seven states—Alaska, California, Montana, New Mexico, Oregon, Texas and Washington, with system offices in Renton, Wash., and Irvine, Calif. Learn about our vision of health for a better world at Providence.org and about Providence Genomics here.

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 subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission.

For more information, visit grail.com.

About Galleri^®

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect a shared cancer signal 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 health care 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 galleri.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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