GRAIL to Present New Data on Galleri® and its Methylation Platform at American Association for Cancer Research (AACR) Annual Meeting
GRAIL (NASDAQ: GRAL) will present new data on its Galleri® multi-cancer early detection (MCED) test at the AACR Annual Meeting in Chicago, April 25-30, 2025. The presentations include real-world evidence from over 100,000 patients, validating the test's capability to detect multiple cancers and accurately predict cancer signal origin.
Key findings include:
- Confirmation of the test's ability to detect cancer signals across various cancer types, particularly those without recommended screening
- Evidence showing reduced cancer risk for one year post-blood draw in patients receiving negative results
- Data supporting annual screening recommendations
- New insights from GRAIL's ctDNA-based targeted methylation platform, demonstrating potential for cancer subtyping through blood samples
GRAIL (NASDAQ: GRAL) presenterà nuovi dati sul suo test Galleri® per la rilevazione precoce di più tipi di cancro (MCED) durante l'AACR Annual Meeting a Chicago, dal 25 al 30 aprile 2025. Le presentazioni includono evidenze reali raccolte da oltre 100.000 pazienti, che confermano la capacità del test di individuare diversi tipi di tumore e di prevedere con precisione l'origine del segnale tumorale.
Principali risultati:
- Conferma dell'efficacia del test nel rilevare segnali tumorali in diversi tipi di cancro, in particolare quelli per cui non esistono screening raccomandati
- Prove che dimostrano una riduzione del rischio di cancro per un anno dopo il prelievo di sangue nei pazienti con risultati negativi
- Dati a sostegno delle raccomandazioni per uno screening annuale
- Nuove scoperte dalla piattaforma di metilazione mirata basata sul ctDNA di GRAIL, che mostrano il potenziale per la sottotipizzazione del cancro tramite campioni di sangue
GRAIL (NASDAQ: GRAL) presentará nuevos datos sobre su test Galleri® de detección temprana de múltiples tipos de cáncer (MCED) en la Reunión Anual de AACR en Chicago, del 25 al 30 de abril de 2025. Las presentaciones incluyen evidencia del mundo real de más de 100,000 pacientes, que validan la capacidad del test para detectar múltiples tipos de cáncer y predecir con precisión el origen de la señal cancerígena.
Hallazgos clave:
- Confirmación de la capacidad del test para detectar señales de cáncer en varios tipos, especialmente aquellos sin programas de detección recomendados
- Evidencia que muestra una reducción del riesgo de cáncer durante un año tras la toma de sangre en pacientes con resultados negativos
- Datos que respaldan las recomendaciones para el cribado anual
- Nuevos conocimientos de la plataforma de metilación dirigida basada en ctDNA de GRAIL, que demuestran potencial para la subtipificación del cáncer mediante muestras de sangre
GRAIL (NASDAQ: GRAL)은 2025년 4월 25일부터 30일까지 시카고에서 열리는 AACR 연례회의에서 Galleri® 다중 암 조기 발견(MCED) 검사에 대한 새로운 데이터를 발표할 예정입니다. 발표 내용에는 10만 명 이상의 환자 데이터를 기반으로 한 실제 증거가 포함되어 있으며, 이 검사의 여러 암을 탐지하고 암 신호의 기원을 정확히 예측하는 능력을 입증합니다.
주요 발견 사항:
- 권장되는 선별검사가 없는 암 유형을 포함한 다양한 암 신호를 탐지하는 검사 능력 확인
- 음성 결과를 받은 환자에서 혈액 채취 후 1년간 암 위험 감소 증거
- 연간 선별검사 권고를 뒷받침하는 데이터
- GRAIL의 ctDNA 기반 표적 메틸화 플랫폼에서 얻은 새로운 통찰력으로, 혈액 샘플을 통한 암 아형 분류 가능성 제시
GRAIL (NASDAQ : GRAL) présentera de nouvelles données sur son test Galleri® de détection précoce de plusieurs cancers (MCED) lors de la réunion annuelle de l'AACR à Chicago, du 25 au 30 avril 2025. Les présentations incluent des preuves issues du monde réel provenant de plus de 100 000 patients, validant la capacité du test à détecter plusieurs cancers et à prédire avec précision l'origine du signal tumoral.
Principaux résultats :
- Confirmation de la capacité du test à détecter des signaux cancéreux dans différents types de cancers, notamment ceux sans dépistage recommandé
- Preuves montrant une réduction du risque de cancer pendant un an après la prise de sang chez les patients avec un résultat négatif
- Données soutenant les recommandations de dépistage annuel
- Nouvelles perspectives issues de la plateforme de méthylation ciblée basée sur l’ADN circulant tumoral (ctDNA) de GRAIL, démontrant un potentiel de sous-typage des cancers à partir d’échantillons sanguins
GRAIL (NASDAQ: GRAL) wird neue Daten zu seinem Galleri® Multi-Krebs-Früherkennungstest (MCED) auf dem AACR Jahreskongress in Chicago vom 25. bis 30. April 2025 vorstellen. Die Präsentationen umfassen Real-World-Daten von über 100.000 Patienten, die die Fähigkeit des Tests bestätigen, verschiedene Krebsarten zu erkennen und den Ursprung des Krebs-Signals präzise vorherzusagen.
Wesentliche Erkenntnisse:
- Bestätigung der Fähigkeit des Tests, Krebs-Signale bei verschiedenen Krebsarten zu erkennen, insbesondere bei solchen ohne empfohlene Screening-Programme
- Nachweise, die ein reduziertes Krebsrisiko für ein Jahr nach Blutentnahme bei Patienten mit negativen Ergebnissen zeigen
- Daten, die die Empfehlung für jährliche Screenings unterstützen
- Neue Erkenntnisse von GRAILs ctDNA-basierter zielgerichteter Methylierungsplattform, die das Potenzial zur Krebsuntertypisierung anhand von Blutproben aufzeigen
- None.
- None.
Real-World Data in 100,000 Patients Further Support the Galleri® Test's Ability to Simultaneously Screen for Multiple Cancers, as Well as its Accuracy of Cancer Signal of Origin Prediction to Support More Efficient Diagnostic Evaluations
Data From GRAIL's ctDNA-based Targeted Methylation Assay Highlight Potential to Identify Robust Signals of Promoter Methylation
"GRAIL has an extensive evidence program that is setting the standard for multi-cancer early detection development that includes a large real-world dataset demonstrating Galleri test performance and implementation," said Josh Ofman, MD, MSHS, President of GRAIL. "The real-world findings being presented at AACR support those observed in our previous clinical studies, highlighting the test's ability to screen for deadly cancers that do not have recommended screening tests. Additional data presented will underscore the potential of GRAIL's ctDNA-based targeted methylation assay for quantifying abnormal promoter methylation, which is a known hallmark of cancer and has shown potential utility as a biomarker in precision oncology."
Data Presentations
Title: Real-world data and clinical experience from over 100,000 multi-cancer early detection tests
Abstract Number: 7202
Session Title: Targeted Therapies and Combinations 4
Date/Time: April 30, 2025, 9 am-12 pm
Location: Poster section 35
- The latest data from a real-world study of more than 100,000 participants with the Galleri test, consistent with previously reported large-scale clinical data, affirming the MCED test can reliably detect a cancer signal across a wide range of cancer types, including cancers without recommended screening, with a high Cancer Signal of Origin prediction accuracy to help guide diagnostic evaluations.
Title: Estimated Post-Test Probabilities of Cancers For Individuals Receiving Multi-Cancer Early Detection (MCED) Tests
Abstract Number: 7132
Session Title: Immune Monitoring / Clinical Correlates
Date/Time: April 30, 2025, 9 am-12 pm
Location: Poster section 31
- This modeling analysis shows that individuals receiving a no cancer signal detected MCED test result have a reduced risk of cancer diagnosis for one year post-blood draw; this risk increases as screening interval goes beyond one year, highlighting the importance of annual screening with the MCED test.
Title: Promoter Methylation as a Cancer Biomarker: Insights From ctDNA-Based Targeted Methylation Data
Abstract Number: 1943
Session Title: Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2
Date/Time: April 28, 2025, 9 am-12 pm
Location: Poster section 28
- Leveraging insights from the Circulating Cell-free Genome Atlas (CCGA) study, this early proof-of-concept study underscores the potential of GRAIL's ctDNA-based targeted methylation assay for detecting clinically informative promoter methylation signals in a plasma sample.
Title: Assessment of Cancer Subtypes Across Multiple Cancer Types Using a Circulating Tumor DNA (ctDNA)-Based Targeted Methylation Assay
Abstract Number: 1947
Session Title: Liquid Biopsy: Circulating Nucleic Acids 5 / Circulating Tumor Cells 2
Date/Time: April 28, 2025, 9 am-12 pm
Location: Poster section 28
- Based on this proof-of-concept study, GRAIL's ctDNA-based targeted methylation assay enables subtyping across cancers using a single blood draw, without the need for invasive tissue biopsy.
About GRAIL
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 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 the Galleri® Test
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood draw, the Galleri test can identify DNA shed by cancer cells, which can act as a unique "fingerprint" of cancer, 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. The Galleri test is recommended for adults with an elevated risk for cancer, such as those aged 50 or older.
For more information, visit galleri.com.
Sensitivity in study participants with –
Pancreas cancer:
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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 No Cancer Signal 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
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 Food and Drug Administration. The GRAIL clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.
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 about or projections of Galleri performance, Galleri clinical impact, proof of concept results that could support future products or product improvements, technology, clinical and real world studies, regulatory compliance, potential market opportunity, anticipated growth strategies, and other topics.
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 and numerous associated risks discussed under the section entitled "Risk Factors" in our Annual Report on Form 10-K for the period ended December 31, 2024 (the "Form 10-K"). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make.
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.
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SOURCE GRAIL, Inc.
FAQ
What are the key findings from GRAIL's 100,000-patient Galleri test study being presented at AACR 2025?
How often should patients get the Galleri MCED test according to GRAL's latest research?
What advantages does GRAL's ctDNA-based targeted methylation assay offer for cancer detection?
When and where will GRAL present its latest Galleri test data?
What types of cancer can the Galleri MCED test detect?
