Point32Health and GRAIL Expand Pilot Access to Galleri® Multi-Cancer Early Detection Blood Test

Test is now available to certain Point32Health members who receive primary care with Mass General Brigham affiliated providers

Point32Health, the parent company of Harvard Pilgrim Health Care and Tufts Health Plan, and GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri® multi-cancer early detection screening test. The pilot includes members meeting eligibility requirements whose primary care provider (PCP) is a Mass General Brigham affiliated provider and who are covered under a Harvard Pilgrim Health Care or Tufts Health Plan employer-sponsored plan or a Harvard Pilgrim Health Care Massachusetts Connector plan.

“At Point32Health, we are proud to offer cutting-edge, innovative solutions that focus on improving the health and wellness of our members and the communities we serve,” said Cain A. Hayes, president and CEO at Point32Health. “We are excited to expand our pilot to include Mass General Brigham by offering members this early detection screening test that could potentially save countless lives.”

Point32Health is the first commercial health plan in the U.S. to work with GRAIL to offer its Galleri screening test in addition to recommended cancer screenings. The initial pilot program enabled access to Galleri at no cost for eligible Point32Health employees and Harvard Pilgrim Health Care members who purchase their insurance on the Maine health insurance marketplace. The expansion of the pilot will now enable access for Point32Health’s Commercial Tufts Health Plan or Harvard Pilgrim Health Care members who meet eligibility requirements for the test and whose primary care provider is a Mass General Brigham affiliated provider. As part of this pilot, Mass General Cancer Center’s Early Detection and Diagnostics Clinic will assess eligible participants for cancer risk and have the test available for those members at no cost.

“Early detection and diagnosis of cancer can save lives,” said Lecia V. Sequist, MD, MPH, Landry Family Professor of Medicine at Harvard Medical School and the Program Director of the Cancer Early Detection and Diagnostics Clinic at Mass General Cancer Center. “Our clinic assists patients and their referring providers who are concerned they have cancer or are at increased risk of developing it. Advances in personalized screenings and risk assessments are critical to helping us catch cancer earlier and enabling us to begin treatment sooner.”

In a clinical study, the Galleri test demonstrated the ability to detect a shared cancer signal across more than 50 types of cancer, 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 predict the cancer signal origin with high accuracy.

“A new, population-scale approach for screening people for cancers before symptoms appear may result in finding many more cancers in earlier stages, when outcomes are more likely to be favorable. Dramatically increasing the number of cancers detected by screening holds the potential to reduce the impacts of late stage cancer,” said Josh Ofman, MD, MSHS, president at GRAIL. “We applaud Point32Health and its forward-thinking approach to multi-cancer early detection. We are excited to expand the pilot and increase access to Galleri to the Mass General Brigham network, which shares a commitment to bridging the gap between clinical care and research in cancer screening and detection.”

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 percent of cancer deaths are from cancers that lack recommended early detection screening.

About Point32Health

Point32Health is a leading, health and wellbeing organization, delivering a better health care experience to our members and the communities we serve. One of the top twenty health plans in the United States, Point32Health builds on the quality of our founding organizations, Tufts Health Plan and Harvard Pilgrim Health Care.

At Point32Health, we believe that everyone should have equitable access to affordable, high-quality health care, regardless of their age, race, ethnicity, socioeconomic status, orientation, gender identity or ability. We offer a diverse range of health plans that help improve the health and wellness of the 2 million members we serve. Every day, we work to deliver on our purpose of guiding and empowering healthier lives for everyone.

We are proud that our Harvard Pilgrim Health Care Commercial Combined HMO and POS plans in Massachusetts and Maine, our Exchange HMO plans in Massachusetts and Maine, as well as Tufts Health Plan’s Medicaid and Exchange HMO plans, have received full Health Equity Accreditation from the National Committee for Quality Assurance (NCQA).* And for the eighth straight year, our Tufts Medicare Preferred HMO plan received a 5-star rating from the Centers for Medicare & Medicaid Services, the highest rating possible.**

**NCQA’s Health Equity Accreditation program

*Every year, Medicare evaluates plans based on a 5-Star rating system. Star Ratings are calculated each year and may change from one year to the next. For more information on plan ratings, go to www.medicare.gov. Tufts Medicare Preferred HMO plans received 5 out of 5 stars for contract years

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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