Charles Atwood, MD, VA’s Center for Health Equity Research and Promotion
PITTSBURGH — Veterans comprise nearly one-third of the participants in a major study evaluating a multi-cancer, early-detection blood test. The goal is to find cancers before veterans experience symptoms or the cancer spreads, so that the VA can offer treatment when it is most likely to be effective and potentially curative.
Ten VA sites will participate, starting with the VA Pittsburgh Healthcare System. Ultimately, the program aims to screen 10,000 veterans as part of an observational, multi-center, real-world evidence study that will enroll a total of 35,000 participants.
Through a collaborative effort between the VA, the Veterans Health Foundation (formerly the Veterans Research Foundation of Pittsburgh), and Menlo Park, Calif.-based Grail LLC, the REFLECTION study will provide a blood test or liquid biopsy designed to detect more than 50 types of cancers to eligible veterans. Forty-five of those cancers have no recommended screenings and so are often only detected once they advance or in the course of treating other conditions.
“Cancer is a significant issue for U.S. veterans, many of whom are at high risk,” said Charles Atwood, MD, a pulmonologist, core investigator at the VA’s Center for Health Equity Research and Promotion, lead researcher on the REFLECTION study at the Pittsburgh VAMC and associate professor of medicine at the University of Pittsburgh. “Grail’s multi-cancer, early-detection test will be provided to veterans, in addition to current recommended screenings, with the aim of improving early diagnoses and outcomes.”
Of the 9 million veterans who receive care through the VA annually, 1.2 million or more than 13% have had a cancer diagnosis. Every year, 43,000 veterans are newly diagnosed with a malignancy and 450,000 receive treatment through the VA.
To improve care and outcomes for veterans with cancer, the VA’s National Precision Oncology Program has undertaken a wide range of programs since its launch in 2016. With many screenings delayed because of the pandemic, the VA recently ramped up screening efforts for the five common malignancies that have recommended screening for large populations: breast, colorectal, lung, cervical and prostate cancer. The VA has also increased its efforts to increase awareness of bladder cancer among veterans, as many have increased risk as a result of exposure to factors including Agent Orange, Camp Lejeune’s contaminated water supplies from 1953 through 1987 and PFAS firefighting foam and resulting water contamination.
In addition, the agency established a new program that aims to characterize the increased risk veterans face for rare cancers, which account for 16% of all cancer diagnoses among veterans, with a goal of reducing time to diagnosis, increasing access to targeted therapies and clinical trials, undertaking genomic testing to identify military exposures potentially associated with these cancers and managing structural and therapeutic factors to reduce inequities in care.
Simple Blood Draw
Grail’s Galleri test uses machine learning and advanced genomics to identify cancer signals and determine the source of that signal so that subsequent workups can confirm the result. The test detects abnormalities in the methylation patterns of cell-free DNA that could indicate the presence of cancer, then evaluates that signal to pinpoint its source.
A study presented at the American Association for Cancer Research found that the test had 99.5% specificity and was 89% accurate in identifying the source of a cancer signal in participants aged 50 to 79.1
The test does not pick up cancers, however, and is designed for use in conjunction with other recommended cancer screenings. A second study found that the test correctly identified the presence of cancer 51.5% of the time in participants who had recently received a cancer diagnosis, but accurately predicted the origin of that cancer signal 88.7% of the time. Participants in the study who did not have cancer received a false positive result in 0.5% of cases.2
Malignancies detected by the test include the cancers for which adults are often screened, as well as those notoriously difficult to diagnose early in their progression, such as cancers of the pancreas, kidney, ovaries and liver, plus several sarcomas.
“As the largest national integrated health system in the U.S., the VA delivers unparalleled care to our veterans, many of whom are at elevated risk of developing cancer. We are thrilled to collaborate with the VA, the Veterans Health Foundation and U.S. veterans for this important real-world evaluation of the Galleri test and its potential to transform early cancer detection,” said Bob Ragusa, chief executive officer at Grail. “Together, we hope participation in the REFLECTION registry study and receiving a Galleri test will lead to more cancer diagnoses at an earlier stage, when treatment is more likely to be successful.”
- Klein E, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test. Oral presentation at: American Association for Cancer Research; April, 2021; LB013.
- Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021;32(9):1167 – 1177. doi: 10.1016/j.annonc.2021.05.806.
