On October 23, 2024 GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, reported early results from the REFLECTION study, which aims to understand the real-world experience of the Galleri multi-cancer early detection (MCED) test in routine clinical settings (Press release, Grail, OCT 23, 2024, View Source [SID1234647349]). The Galleri test is recommended for adults with an elevated risk for cancer, such as those age 50 or older. In this study, a diverse population of veterans from U.S. Department of Veterans Affairs (VA) sites with toxic exposure but with no symptoms suggestive of cancer were included in study enrollment. Initial results showed that among study participants, the veteran cohort had a cancer signal detection rate consistent with other populations that have received the MCED test. The findings were presented during a presentation at the 2024 Early Detection of Cancer Conference (EDCC).
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Overall, the cancer signal detection rate in this veteran cohort was 1.30% (37/2854 participants; 95% CI: 0.94% – 1.78%), which is consistent with other populations that have received the MCED test (0.88%1 and 0.95%2). Among the 37 participants with a Cancer Signal Detected (CSD) at the time of analysis, 28 completed 180 days of follow-up, and of these, 12 cancer diagnoses were confirmed. More than half of the cases were identified at early stages (I-III) and the most common cancer signal of origin prediction was lung cancer (7). A positive predictive value (PPV), meaning that the test accurately detects a signal for cancer in someone that has cancer, was 42.9%, which is consistent with PPVs from previous Galleri testing datasets.1,3 Additional cancers could be diagnosed during the remainder of the one-year follow-up period.
"While today doctors screen individually for five specific cancers, nearly 70% of cancers have no recommended screening tests. With 50,000 veterans diagnosed with cancer every year, these initial findings from REFLECTION showing a consistent cancer signal detection rate among the veteran cohort suggest that when added to recommended screenings, MCED tests like Galleri may address an unmet medical need," said Charles Atwood, M.D., pulmonologist and lead researcher on the REFLECTION study at VA Pittsburgh. "We look forward to longer-term data that will provide veteran-reported experience with MCED testing and cancer outcomes that may provide additional insights for veterans with service-related toxic exposures."
The REFLECTION study (NCT05205967) is a multi-center, prospective, non-interventional, cohort study designed to understand the real-world experience of Galleri in clinical settings. This initial analysis included data from seven VA sites with 180 days of post-test follow-up. A total of 2,924 veterans were enrolled in the study at the time of the analysis and 2,854 are analyzable in these initial study data. Within the veteran cohort with data, 70% of participants had been exposed to one or more toxic environmental or occupational hazards during their service, including open burn pits/airborne hazards, Gulf War-related exposures, Agent Orange, radiation and others. The study included recruitment of veterans aged ≥22 years. The mean age of the cohort was 60 years old and the cohort was 79% male.
"With many veterans at elevated risk of developing cancer, the initial results from the REFLECTION study provide important insights into the impact of MCED testing to help transform early cancer detection in a real-world setting," said Josh Ofman, MD, MSHS, President at GRAIL. "We’re honored to be working with the VA, the largest national integrated health system in the U.S., to evaluate how Galleri can screen for many of the deadliest cancers before they become symptomatic, when there may be more treatment options."
About the REFLECTION Study
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 17,000 individuals who have opted to be screened with the Galleri, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri in clinical settings. Patients who have been prescribed the Galleri test as part of medical care by their healthcare provider will have the opportunity to consent for participation into this data collection study and will be actively followed for 12 months from the time of enrollment through data capture from electronic health records and periodic self-report questionnaires.