FirstHealth of the Carolinas to Offer GRAIL’s Galleri®, a Multi-Cancer Early Detection Blood Test

PINEHURST, N.C. & MENLO PARK, Calif.--(BUSINESS WIRE)-- FirstHealth of the Carolinas, Inc., a private, not-for-profit health system serving patients in 15 counties in the mid-Carolinas, and GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced the availability of Galleri^Ⓡ, a multi-cancer early detection (MCED) screening test to eligible patients initially through FirstHealth’s Concierge Medicine Clinic in Southern Pines. FirstHealth will be the first health system in North Carolina to offer the Galleri MCED test to those at an elevated risk of cancer, including those aged 50 or older, as part of its comprehensive cancer screening and care. Additional primary care clinics will offer the test in the coming months.

“As a leader in cancer detection and treatment, FirstHealth is proud to support those in our community with an elevated risk of cancer with access to comprehensive cancer care,” said Dan Barnes, D.O., President of FirstHealth Physician Group. “We are committed to providing patients with groundbreaking technologies like the Galleri MCED test close to home.”

In a clinical study, the Galleri test demonstrated the ability to detect a shared cancer signal across 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 a cancer signal is detected, Galleri can determine the cancer signal origin with high accuracy, enabling clinicians to focus their diagnostic evaluation.

“Our partnership with FirstHealth represents our joint commitment to bringing innovative, high-quality technologies to communities with the aim to transform cancer screening and early detection,” said Jeffrey Venstrom, MD, Chief Medical Officer at GRAIL. “By potentially identifying cancers earlier, MCED technology allows healthcare providers to provide people with the necessary diagnostic evaluations and, if needed, get them into treatment more quickly, when it is more likely to be successful.”

More than 609,000 people die from cancer each year in the U.S., according to the American Cancer Society. This is in large part because some of the deadliest cancers are found too late when outcomes are often poorer. 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 71% of cancer deaths are from cancers that lack recommended early detection screening.

To learn more about the Galleri^Ⓡ MCED test offered through FirstHealth Concierge Medicine, call (800) 213-3284.

About FirstHealth of the Carolinas

FirstHealth of the Carolinas, Inc., a private, not-for-profit health care network, is headquartered in Pinehurst, NC. Its 5,600 employees serve 15 counties in the mid-Carolinas. Licensed for four hospitals with 610 beds, FirstHealth demonstrates a commitment to treating the whole patient and to providing quality health care for the entire community—especially those in need.

FirstHealth is committed to patient safety, quality and performance excellence.

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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