GRAIL Presents Initial Results From REFLECTION Real-World Evidence Study of Galleri® Multi-Cancer Early Detection (MCED) Test at the Early Detection of Cancer Conference
GRAIL announced initial results from the REFLECTION study evaluating the Galleri® multi-cancer early detection (MCED) test in veterans. The study, conducted across seven VA sites, showed a cancer signal detection rate of 1.30% (37/2854 participants) among veterans with toxic exposure, consistent with other populations. Of 28 participants completing 180-day follow-up, 12 cancer diagnoses were confirmed, with over half identified at early stages (I-III). The test demonstrated a positive predictive value of 42.9%. The study included veterans aged ≥22 years (mean age 60), with 70% exposed to toxic hazards during service. Lung cancer was the most common cancer signal detected.
GRAIL ha annunciato i risultati iniziali dello studio REFLECTION che valuta il test di rilevamento precoce del cancro Galleri® (MCED) tra i veterani. Lo studio, condotto in sette sedi VA, ha mostrato un tasso di rilevamento del segnale di cancro del 1,30% (37/2854 partecipanti) tra i veterani con esposizione a tossine, in linea con altre popolazioni. Di 28 partecipanti che hanno completato un follow-up di 180 giorni, sono state confermate 12 diagnosi di cancro, con oltre la metà identificate in stadi precoci (I-III). Il test ha dimostrato un valore predittivo positivo del 42,9%. Lo studio ha incluso veterani di età ≥22 anni (età media 60), con il 70% esposti a pericoli tossici durante il servizio. Il cancro ai polmoni è stato il segnale di cancro più comune rilevato.
GRAIL anunció los resultados iniciales del estudio REFLECTION que evalúa la prueba de detección temprana de múltiples cánceres Galleri® (MCED) en veteranos. El estudio, realizado en siete sitios de VA, mostró una tasa de detección de señales de cáncer del 1,30% (37/2854 participantes) entre veteranos con exposición a toxinas, consistente con otras poblaciones. De 28 participantes que completaron un seguimiento de 180 días, se confirmaron 12 diagnósticos de cáncer, y más de la mitad fueron identificados en etapas tempranas (I-III). La prueba demostró un valor predictivo positivo del 42,9%. El estudio incluyó a veteranos de ≥22 años (edad media de 60), con un 70% expuestos a peligros tóxicos durante el servicio. El cáncer de pulmón fue la señal de cáncer más común detectada.
GRAIL은 퇴역 군인을 대상으로 한 Galleri® 다중 암 조기 발견(MCED) 테스트를 평가하는 REFLECTION 연구의 초기 결과를 발표했습니다. 이 연구는 7개의 VA 사이트에서 진행되었으며, 독성에 노출된 퇴역 군인들 사이에서 암 신호 탐지 비율이 1.30% (2854명 중 37명)로 나타났으며, 이는 다른 집단과 일치합니다. 180일 추적 관찰을 완료한 28명 중 12명의 암 진단이 확인되었고, 그 중 절반 이상이 초기 단계(I-III)에서 발견되었습니다. 이 테스트는 양성 예측 값이 42.9%임을 증명했습니다. 연구에는 22세 이상의 퇴역 군인(평균 연령 60세)이 포함되었으며, 그 중 70%는 복무 중 독성 위험에 노출되었습니다. 폐암이 탐지된 가장 일반적인 암 신호였습니다.
GRAIL a annoncé les résultats préliminaires de l'étude REFLECTION évaluant le test de détection précoce de plusieurs cancers Galleri® (MCED) chez les vétérans. L'étude, réalisée dans sept sites de la VA, a montré un taux de détection des signaux de cancer de 1,30% (37/2854 participants) parmi les vétérans exposés à des toxines, cohérent avec d'autres populations. Parmi les 28 participants ayant réalisé un suivi de 180 jours, 12 diagnostics de cancer ont été confirmés, plus de la moitié étant identifiés à des stades précoces (I-III). Le test a démontré un valeur prédictive positive de 42,9%. L'étude a inclus des vétérans de ≥22 ans (âge moyen 60), avec 70% exposés à des dangers toxiques durant leur service. Le cancer du poumon était le signal de cancer le plus fréquemment détecté.
GRAIL gab die ersten Ergebnisse der REFLECTION-Studie bekannt, die den Galleri®-Test zur frühzeitigen Erkennung mehrerer Krebsarten (MCED) bei Veteranen bewertet. Die Studie, die an sieben VA-Standorten durchgeführt wurde, zeigte eine Krebsignal-Erkennungsrate von 1,30% (37/2854 Teilnehmer) bei Veteranen mit toxischer Exposition, konsistent mit anderen Bevölkerungsgruppen. Bei 28 Teilnehmern, die eine 180-tägige Nachuntersuchung abgeschlossen hatten, wurden 12 Krebsdiagnosen bestätigt, wobei mehr als die Hälfte in den frühen Stadien (I-III) identifiziert wurde. Der Test zeigte einen positiven prädiktiven Wert von 42,9%. Die Studie umfasste Veteranen im Alter von ≥22 Jahren (Durchschnittsalter 60), wobei 70% während ihres Dienstes toxischen Gefahren ausgesetzt waren. Bronchialkarzinome waren das am häufigsten detektierte Krebsignal.
- Cancer signal detection rate of 1.30% aligned with previous population results
- 42.9% positive predictive value consistent with previous datasets
- More than 50% of detected cancers were identified at early stages (I-III)
- Successfully detected cancer signals in veterans with toxic exposure risk factors
- None.
Insights
The REFLECTION study results demonstrate significant progress in multi-cancer early detection technology, with the Galleri test showing consistent performance in a veteran population. The
Key findings include the detection of 12 confirmed cancer cases from 28 follow-up completions, with most identified in early stages (I-III). The study's focus on veterans with toxic exposure histories adds valuable data about MCED effectiveness in high-risk populations. The inclusion of 7 VA sites and 2,854 analyzable participants provides a robust dataset for real-world implementation assessment.
While promising, investors should note that the study is ongoing and additional cancer diagnoses may emerge during the remaining follow-up period. The test's potential market impact is substantial, considering
This development represents a significant market opportunity in the cancer screening sector. With 50,000 veterans diagnosed with cancer annually and
The consistent performance metrics across different populations strengthen Galleri's market positioning. The early-stage detection capability is particularly valuable, as it can lead to better treatment outcomes and reduced healthcare costs. For investors, this validates the commercial viability of GRAIL's technology and suggests potential for expanded insurance coverage and reimbursement opportunities.
Study Participants from Veteran Affairs Sites Include a Diverse Population With Toxic Exposure
Overall, the cancer signal detection rate in this veteran cohort was
"While today doctors screen individually for five specific cancers, nearly
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,
"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
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.
About GRAIL, Inc.
GRAIL, Inc. 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 using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art machine learning, software, and automation to detect and identify multiple deadly cancer types in earlier stages. GRAIL's targeted methylation-based platform can support the continuum of care for screening and precision oncology, including multi-cancer early detection in symptomatic patients, risk stratification, minimal residual disease detection, biomarker subtyping, treatment and recurrence monitoring. GRAIL is headquartered in
For more information, visit grail.com.
About Galleri®
The Galleri multi-cancer early detection test is a proactive tool in finding cancer early. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells (unique "fingerprints") to help screen for some of the deadliest cancers that don't have recommended screening today, such as pancreatic, esophageal, ovarian, liver, and others.* The Galleri test can be used to screen for cancer before a person becomes symptomatic, when cancer may be more easily treated and potentially curable. The Galleri test can indicate the origin of the cancer, giving healthcare providers a roadmap of where to explore further. The Galleri test requires a prescription from a licensed healthcare 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 recommended for people over the age of 50, or those with an elevated risk for cancer due to genetics, family history, environmental exposure, or other risk factors.
For more information about Galleri, visit galleri.com
Laboratory/Test Information
The GRAIL 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
Forward Looking Statements
This press release contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as "aim," "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "should," "would," or "will," the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations and projections of test performance , clinical study results, regulatory compliance, potential market opportunity, anticipated growth strategies, and anticipated trends in our business.
These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors discussed under the section entitled "Risk Factors" in the Quarterly Report on Form 10-Q for the period ended June 30, 2024 and in GRAIL's other filings with the
Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this press release to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events. Footnotes:
- Schrag D et al. Lancet. 2023;402(10409):1251-1260.
- Westgate C et al. Poster presented at American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023,
Chicago, IL. - Klein et al. Ann Oncol. 2021;32(9):1167-1177.
View original content to download multimedia:https://www.prnewswire.com/news-releases/grail-presents-initial-results-from-reflection-real-world-evidence-study-of-galleri-multi-cancer-early-detection-mced-test-at-the-early-detection-of-cancer-conference-302285125.html
SOURCE GRAIL, Inc.
FAQ
What was the cancer detection rate in GRAIL's REFLECTION study for veterans?
How many confirmed cancer diagnoses were found in GRAIL's REFLECTION study?
What was the positive predictive value (PPV) of the Galleri test in the REFLECTION study?
What percentage of veterans in GRAIL's REFLECTION study had toxic exposure?
