MENLO PARK, Calif., and CANTON, Mass., Feb. 15, 2022 — GRAIL, LLC, a health care company with a mission of detecting cancer early when it can be cured, today announced an agreement with Point32Health, the combined organization of Harvard Pilgrim Health Care and Tufts Health Plan, to collaborate on a two-phased pilot of Galleri®, GRAIL’s groundbreaking multi-cancer early detection blood test. Point32Health is the first commercial health plan in the U.S. to work with GRAIL on its Galleri multi-cancer early detection (MCED) test as a complement to recommended cancer screenings.
“Point32Health is proud to be a leader in health care services by delivering innovative medical advances that focus on improving the health and wellness of our colleagues and members,” said Cain A. Hayes, president and CEO at Point32Health. “We are thrilled to be the first commercial health plan in the United States to collaborate with GRAIL on Galleri, which has the potential to be a game-changing screening tool that could be life-saving for people in the early detection of cancer.”
Point32Health’s implementation of the Galleri test will begin with Point32Health employees who meet certain eligibility criteria, including age and family history of cancer. The goal for the second phase is to collaborate with a provider group serving Point32Health commercial members that will help collect real-world evidence to assess the impact of the test on health care resource utilization and patient-reported outcomes.
“We are thrilled to collaborate with GRAIL to offer this innovative, first-of-its-kind test to eligible colleagues at Point32Health and to a group of members in the second phase of our pilot,” said Michael Sherman, MD, MBA, MS, executive vice president and chief medical officer at Point32Health. “GRAIL’s pioneering, science-based-technology, could be revolutionary for the thousands of people and their families impacted by cancer.”
In a clinical study, the Galleri test 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 percent. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy.
“The toll that cancer takes on our communities is unacceptable. We at GRAIL have harnessed the power of genomics and machine learning with the sole goal of meaningfully improving cancer outcomes,” said Josh Ofman, MD, MSHS, president and chief medical officer at GRAIL. “By working with Point32Health, a company known for collaborating with world-class hospitals and health care providers, we are making significant progress aligning with forward-looking companies to detect cancer early when treatments are more effective and there is the potential for a cure.”
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.
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).
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 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.
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.