Leading Health System to Offer Groundbreaking Blood Test to Patients

GRAIL, LLC, a healthcare company whose mission is to detect cancer early, today announced a collaboration with the Knight Cancer Institute at Oregon Health & Science University (OHSU) to offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test. OHSU will provide patients access to Galleri via a pilot program to help find signals of cancer in earlier stages and advance the delivery of cancer care.

Beginning this month, the Galleri test will be offered to eligible patients through the OHSU Knight Cancer Institute. The OHSU Knight Cancer Institute is at the forefront of multi-cancer early detection, including serving as a founding member of the MCED consortium, a group of leading cancer-focused organizations evaluating technologies that have the potential to reduce cancer mortality through earlier detection and providing guidance for their clinical use.

“At GRAIL, we are focused on detecting cancer early, when treatments are more effective and there is potential for cure,” said Dr. Josh Ofman, president and chief medical officer at GRAIL. “We are honored to work alongside the preeminent team of researchers and clinicians at the OHSU Knight Cancer Institute who share our vision and are committed to bringing their patients the benefits of earlier cancer detection.”

More than 600,000 people die from cancer each year in the U.S., 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 smokers, lung. In fact, 71% of cancer deaths have no recommended early detection screening at all.

“Multi-cancer early detection is a true game-changing technology in how we detect and treat cancer,” said Tom Beer, M.D., deputy director of the OHSU Knight Cancer Institute and chief medical officer of the Knight Cancer Institute’s Cancer Early Detection Advanced Research (CEDAR) Program. “After evaluating how the Galleri test worked in the clinical trial setting, we are now able to offer eligible patients access to the test.”

In a clinical study, Galleri demonstrated the ability to detect more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1%. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

OHSU is also a leading partner in the interventional PATHFINDER 2 study evaluating the implementation and performance of Galleri in a clinical care setting. Initial results from the first PATHFINDER study were presented by Dr. Beer at the 2021 ASCO Annual Meeting and demonstrated Galleri’s performance was consistent with findings from previous observational studies, underscoring the potential real-world ability of Galleri to find deadly cancers earlier.

About Galleri

The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect 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

Galleri 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.

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. Galleri is prescription 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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