New Cancer Screening Available for Veterans

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The Department of Veterans Affairs and the Veterans Health Foundation have partnered with GRAIL, LLC, to provide veterans access to GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test. GRAIL will make its Galleri MCED test available to 10,000 veterans across approximately 10 sites over the next three years. VA Pittsburgh Healthcare System will pilot the program.

The blood-screening tests will be offered as part of the REFLECTION clinical real-world evidence study. The study will review if Galleri, along with other standard cancer screenings, can find cancers at an early stage when treatment is most likely to be successful.

Nationwide, 1.2 million veterans who have used VA health care since the beginning of fiscal year 2021 have a cancer diagnosis. That number includes 14% of Veterans treated at VA Pittsburgh in the same time frame.

“Cancer is a leading cause of illness and death for veterans,” said VA Pittsburgh pulmonologist Dr. Charles Atwood, lung cancer screening director and lead researcher on the REFLECTION study. “Our partnership with GRAIL and the Galleri test will help VA expand its efforts in cancer early detection.”

Atwood said the multi-cancer early detection tests will be provided to veterans in addition to current recommended screenings. The aim, he said, is to improve early diagnoses and outcomes.

Early detection of cancer is known to improve outcomes, but most are found in late stages because just five types have recommended screenings — breast, cervical, colon, lung and prostate. In a clinical study, the Galleri test demonstrated the ability to detect 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%. The test also determines the origin of the cancer with high accuracy.

Veterans interested in the Galleri test and REFLECTION study can ask their primary care provider for more information on how to participate.

“We are thrilled to partner with the VA and U.S. veterans for this important evaluation of the Galleri test, alongside recommended standard screenings, for its potential to transform early cancer detection in this at-risk population,” said Bob Ragusa, chief executive officer at GRAIL. “The partnership will help veterans access the REFLECTION registry study and receive a test we hope will lead to more cancer diagnoses at an earlier stage, when treatment is more likely to be successful.”

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ABOUT VA PITTSBURGH HEALTHCARE SYSTEM
VA Pittsburgh Healthcare System (VAPHS) is one of the largest and most progressive VA health care systems in the nation. More than 4,000 employees serve nearly 80,000 veterans every year, providing a range of services from complex transplant medicine to routine primary care. VAPHS is a leader in virtual care delivery through telehealth technology; a center of research and learning with 130 research investigators and $14.8 million in funding in fiscal year 2021; and a provider of state-of-the-art health care training to some 1,500 student trainees annually. VAPHS provides care at medical centers in Pittsburgh's Oakland neighborhood and nearby O’Hara Township, both in Pennsylvania, and five outpatient clinics in Belmont County, Ohio, and Beaver, Fayette, Washington and Westmoreland counties in Pennsylvania. An additional site of care is expected to open in Monroeville, Pennsylvania, in 2023. Veterans can call 412-360-6162 to check eligibility or enrollment. Stay up to date at pittsburgh.va.gov, Facebook and Twitter.

ABOUT VETERANS HEALTH FOUNDATION
Established in 1991, the Veterans Health Foundation (VHF), formerly the Veterans Research Foundation of Pittsburgh, facilitates and supports extramural research and educational activities by collaborating with VA Pittsburgh Healthcare System, private companies, government agencies, foundations and academic institutions. Title 38 USC §7361-7366 authorizes VA medical centers to establish nonprofit research and education corporations to accept and administer private and non-VA federal funds in support of VA's research and education missions. The congressional intent in enabling these corporations is to provide VA facilities with a flexible funding mechanism for the conduct of research as well as staff and patient education.

ABOUT GRAIL
GRAIL is a health care 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, California, 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 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 cancer signals 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 may not detect a cancer signal across all cancers and should be used in addition to routine cancer screening tests recommended by a health care 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 health care 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.

Kimberly Graham, Visual Information Specialist

vaphsmediarelations@va.gov