Point32Health, the parent company of Harvard Pilgrim Health Care, and GRAIL, LLC, a health care company with a mission of detecting cancer early when it can be cured, today announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri^® multi-cancer early detection blood test to Harvard Pilgrim members at no cost who purchase their insurance on the Maine Health Insurance Marketplace. This expansion is the second phase of a pilot focused on collecting real-world evidence to assess the impact of the Galleri test on health care resource utilization and patient-reported outcomes.

“We are proud to be an industry leader in bringing cutting-edge, innovative technologies and services to our members,” said Cain A. Hayes, president and CEO at Point32Health. “We are thrilled to expand our pilot of this game-changing screening tool to a subset of our members in Maine. This test has the potential to change the lives of countless people and their families impacted by cancer.”

Harvard Pilgrim Health Care HMO members on Maine’s insurance marketplace can participate in the second phase of this pilot. Eligible members will be mailed information for how to participate in the pilot. Point32Health is the first commercial health plan in the U.S. to work with GRAIL to offer its Galleri^® test as a complement to recommended cancer screenings. The first phase of the pilot launched earlier this year when Point32Health made the test available at no cost to eligible employees.

“We know that cancer has a critical impact in Maine, with one in three Mainers facing a cancer diagnosis in their lifetime,” said Bill Whitmore, vice president for the Maine market at Harvard Pilgrim Health Care. “This pilot will help facilitate early detection when treatment can be more effective and there is the potential for a cure.”

According to the Maine Cancer Foundation, cancer is the leading cause of death in Maine. The pilot’s expansion to Maine is an opportunity to help people living in an area where cancer rates are significantly higher than the national average. Harvard Pilgrim Health Care recently provided a matching grant to the Maine Cancer Foundation to launch the Maine Cancer Blueprint to help better understand the current state of cancer in Maine.

“Multi-cancer early detection tests, like Galleri, are the future because of their ability to find more cancers earlier, before symptoms appear, with a single blood test,” said Josh Ofman, MD, MSHS, president at GRAIL. “We are delighted to expand our pilot with Point32Health, the first commercial health plan in the U.S. to offer Galleri, following successful implementation of the initial pilot phase with their eligible employees. We believe offering Galleri can help increase early cancer detection in Maine, where cancer rates are significantly higher than the national average.”

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 percent. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.

More than 600,000 people died from cancer last year in the United States, 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 adults) lung. In fact, about seven in 10 cancer deaths are from cancers that lack recommended early detection screening.

About Point32Health

Point32Health is a leading health and wellbeing organization, delivering an ever-better health care experience to everyone in our communities. Building on the quality, nonprofit heritage of our founding organizations, Tufts Health Plan and Harvard Pilgrim Health Care, we leverage our experience and expertise to help people find their version of healthier living through a broad range of health plans and tools that make navigating health and wellbeing easier.

Our programs take a 360-degree view of health for our members—no matter their age, health, race, identity or income. Our Institute works to improve population health—and our Foundation works with communities to support, advocate and advance healthier lives for everyone. We use empathy to understand what’s important to those we serve, always making their priorities our own. And we work to guide and empower people by bringing together wide-ranging partners and perspectives to create new approaches that make a real difference for our community, our industry and our 2.2 million members across New England.

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 www.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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