GRAIL to Present New Galleri® Data From More Than 32,000 Participants Across the PATHFINDER 2, SYMPLIFY and REFLECTION Studies at ESMO Congress 2025 and EDCC
GRAIL (NASDAQ: GRAL) announced it will present new data for its Galleri® multi-cancer early detection (MCED) test at two major conferences. The company will showcase results from the PATHFINDER 2 study, the largest MCED interventional study in the U.S., at the ESMO Congress 2025 in Berlin. The study's top-line results demonstrated that adding Galleri to standard screening led to significantly improved cancer detection and higher positive predictive value compared to the first PATHFINDER study.
Additionally, GRAIL will present data from the SYMPLIFY study focusing on symptomatic participants and the REFLECTION study examining real-world experience in veterans at the Early Detection of Cancer Conference (EDCC) 2025 in Portland. The results will be part of GRAIL's FDA Premarket Approval Application for Galleri.
GRAIL (NASDAQ: GRAL) ha annunciato che presenterà nuovi dati sul suo test Galleri® MCED (multi-cancer early detection) in due importanti conferenze. Presenterà i risultati dello studio PATHFINDER 2, il più grande studio MCED interventivo negli Stati Uniti, al Congresso ESMO 2025 a Berlino. I risultati principali hanno dimostrato che aggiungere Galleri allo screening standard ha portato a un rilevamento del cancro significativamente migliorato e a un valore predittivo positivo più elevato rispetto al primo studio PATHFINDER. Inoltre, GRAIL presenterà dati dallo studio SYMPLIFY focalizzati sui partecipanti sintomatici e dallo studio REFLECTION che esamina l’esperienza reale tra i veterani al EDCC 2025 di Portland. I risultati faranno parte della richiesta di FDA Premarket Approval per Galleri.
GRAIL (NASDAQ: GRAL) anunció que presentará nuevos datos de su prueba Galleri® MCED en dos conferencias importantes. Mostrará los resultados del estudio PATHFINDER 2, el mayor estudio MCED intervencional en EE. UU., en el Congreso ESMO 2025 en Berlín. Los resultados clave demostraron que añadir Galleri al cribado estándar condujo a una detección de cáncer significativamente mejorada y a un mayor valor predictivo positivo en comparación con el primer estudio PATHFINDER. Además, GRAIL presentará datos del estudio SYMPLIFY centrados en participantes sintomáticos y del estudio REFLECTION que examina la experiencia del mundo real en veteranos en la EDCC 2025 en Portland. Los resultados formarán parte de la Solicitud de Aprobación Premarket de la FDA para Galleri.
GRAIL (NASDAQ: GRAL)은 Galleri MCED 검사에 대한 새로운 데이터를 두 차례의 주요 학회에서 발표할 예정이라고 발표했습니다. 미국에서 가장 큰 MCED 개입 연구인 PATHFINDER 2 연구의 결과를 베를린에서 개최되는 ESMO Congress 2025에서 공개합니다. 주요 결과는 표준 선별에 Galleri를 추가하면 암 발견이 크게 향상되고 첫 번째 PATHFINDER 연구에 비해 양성 예측값이 더 높아졌음을 시사합니다. 또한 SYMPLIFY 연구의 데이터를 증상 있는 참가자들을 중심으로, REFLECTION 연구가 재향 군인들의 실제 경험을 다루는 내용을 EDCC 2025에서 포틀랜드에서 발표합니다. 이 결과는 Galleri에 대한 FDA 프리마켓 승인 신청의 일부가 될 것입니다.
GRAIL (NASDAQ : GRAL) a annoncé qu'il présentera de nouvelles données sur son test Galleri® MCED lors de deux grandes conférences. Il exposera les résultats de l'étude PATHFINDER 2, la plus grande étude MCED interventionnelle aux États‑Unis, lors du Congrès ESMO 2025 à Berlin. Les résultats préliminaires ont démontré que l'ajout de Galleri au dépistage standard permettait une détection plus fiable du cancer et une valeur prédictive positive plus élevée par rapport à la première étude PATHFINDER. De plus, GRAIL présentera des données de l'étude SYMPLIFY axées sur les participants symptomatiques et de l'étude REFLECTION examinant l'expérience du monde réel chez les vétérans au « Early Detection of Cancer Conference (EDCC) 2025 » à Portland. Les résultats feront partie de la demande d'autorisation PMA FDA pour Galleri.
GRAIL (NASDAQ: GRAL) hat angekündigt, neue Daten zu seinem Galleri MCED-Test auf zwei großen Konferenzen zu präsentieren. Die Ergebnisse der PATHFINDER 2 Studie, der größten MCED-Interventionsstudie in den USA, werden beim ESMO Congress 2025 in Berlin vorgestellt. Die Top-Line-Ergebnisse zeigten, dass die Ergänzung von Galleri zum Standard-Screening zu deutlich verbesserten Krebsentdeckungen und zu einem höheren positiven Vorhersagewert im Vergleich zur ersten PATHFINDER-Studie führte. Zudem wird GRAIL Daten aus der SYMPLIFY-Studie präsentieren, die sich auf symptomatische Teilnehmer konzentriert, sowie aus der REFLECTION-Studie, die die reale Erfahrung bei Veteranen untersucht, auf der Early Detection of Cancer Conference (EDCC) 2025 in Portland. Die Ergebnisse werden Teil des FDA Premarket Approval-Antrags für Galleri sein.
أعلنت شركة GRAIL (بورصة ناسداك: GRAL) أنها ستعرض بيانات جديدة لاختبار Galleri MCED في مؤتمرين رئيسيين. ستعرض النتائج من دراسة PATHFINDER 2، أكبر دراسة MCED تدخلية في الولايات المتحدة، في مؤتمر ESMO 2025 في برلين. أبرز النتائج أظهرت أن إضافة Galleri إلى فحص الفحص القياسي أدى إلى تحسين كبير في اكتشاف السرطان وزيادة القيمة التنبؤية الإيجابية مقارنةً بالدراسة PATHFINDER الأولى. بالإضافة إلى ذلك، ستعرض GRAIL بيانات من دراسة SYMPLIFY التي تركز على المشاركين ذوي الأعراض والدراسة REFLECTION التي تفحص الخبرة الواقعية لدى المحاربين القدامى في مؤتمر EDCC 2025 في بورتلاند. ستُعد النتائج جزءاً من طلب FDA للموافقة المسبقة على Galleri.
GRAIL（纳斯达克股票代码：GRAL）宣布将于两大会议上展示其 Galleri MCED 疾病早筛测试的新数据。在柏林举行的 ESMO 2025 大会上，将展示 PATHFINDER 2 研究的结果，该研究是美国最大的 MCED 干预研究。初步结果显示，将 Galleri 纳入标准筛查显著提高了癌症检测率并提升了阳性预测值，相较于第一项 PATHFINDER 研究。此外，GRAIL 还将在 EDCC 2025于波特兰展示以症状参与者为焦点的 SYMPLIFY 研究数据，以及考察退伍军人真实世界经验的 REFLECTION 研究数据。这些结果将成为 Galleri 的 FDA 预市场批准申请的一部分。
- Galleri test demonstrated substantially greater additional cancer detection when added to standard screening
- Higher positive predictive value (PPV) compared to first PATHFINDER study
- Cancer signal of origin accuracy and specificity maintained consistency with previous study
- Results will be submitted to FDA as part of Premarket Approval Application
- None.
Insights
GRAIL's Galleri test shows promising cancer detection performance in multiple studies, with FDA submission planned, indicating significant clinical advancement.
GRAIL's upcoming presentation of new Galleri® multi-cancer early detection (MCED) test data represents a potentially significant clinical milestone. The PATHFINDER 2 study results, which will be presented as a late-breaking abstract at ESMO 2025, are particularly notable as they'll form part of the company's FDA Premarket Approval Application. This regulatory submission is a critical step toward potential broader clinical implementation.
The preliminary PATHFINDER 2 results indicate two key performance improvements over the first PATHFINDER study: substantially greater additional cancer detection and higher positive predictive value (PPV) when added to standard screening. Importantly, these results were achieved while maintaining consistent cancer signal origin accuracy and specificity. This suggests the test may effectively address a fundamental challenge in cancer screening – detecting more cancers without increasing false positives.
The SYMPLIFY study data will provide insights into Galleri's performance in symptomatic patients, while REFLECTION will showcase real-world performance in veterans. This comprehensive approach across different populations strengthens Galleri's clinical evidence base.
As the only available MCED test with demonstrated performance in an intended use population being screened for cancer, Galleri's ability to approximately double cancer detection rates when added to standard screening represents a potentially transformative approach to cancer detection. Early detection remains one of the most significant factors in cancer survival outcomes, making these results particularly relevant for clinical practice.
The presentation of GRAIL's PATHFINDER 2 study results at ESMO represents a critical valuation catalyst for the company. This FDA-approved interventional study in over 32,000 participants is specifically designed for regulatory submission, with data already planned for inclusion in GRAIL's Premarket Approval Application to the FDA. The acceptance as a late-breaking presentation at ESMO signals the scientific community's recognition of the data's significance.
The preliminary results indicating substantially improved cancer detection rates and higher positive predictive value compared to the first PATHFINDER study suggest potential clinical utility enhancements that could strengthen GRAIL's market position. The maintenance of consistent cancer signal origin accuracy and specificity addresses key requirements for clinical implementation.
GRAIL's multi-study approach demonstrates strategic foresight in building a comprehensive evidence base across different populations. The SYMPLIFY study examines performance in symptomatic patients, while REFLECTION provides real-world evidence in veterans – both expanding potential applications beyond the primary screening population.
The company's statement about "witnessing the beginning of a transformative era for cancer screening" isn't merely promotional – it reflects the potential market impact of a validated multi-cancer early detection test. With cancer screening representing a multi-billion dollar market opportunity, GRAIL's progress toward potential FDA approval positions the company to potentially capture significant market share in this emerging diagnostic sector.
First PATHFINDER 2 Results Accepted as a Late-Breaking Presentation at the European Society for Medical Oncology (ESMO) Congress 2025; Results to be Submitted to FDA as Part of the Galleri Premarket Approval Application (PMA)
Updated SYMPLIFY and REFLECTION Study Results to be Presented at the Early Detection of Cancer Conference (EDCC) Highlight Galleri Performance in Symptomatic and Veteran Populations, Respectively
As previously reported, top-line results from evaluable PATHFINDER 2 study participants with 12 months of follow-up showed that adding the Galleri test to standard of care screening demonstrated substantially greater additional cancer detection, as well as a substantially higher positive predictive value (PPV), than observed in the first PATHFINDER study. Cancer signal of origin (CSO) accuracy and specificity were consistent with the PATHFINDER study.
In addition, the company will present new Galleri data from the follow-up of symptomatic participants enrolled in SYMPLIFY, a prospective observational study, and real world experience of veterans tested with Galleri from the REFLECTION study at the Early Detection of Cancer Conference (EDCC) 2025 in
"Galleri is the only available MCED test with demonstrated performance in an intended use population being screened for cancer. These new data build on the results from our first clinical implementation study, PATHFINDER, which was published in the Lancet in 2023, and showed that Galleri approximately doubled the number of cancers identified when added to standard of care screening," said Josh Ofman, MD, MSHS, President of GRAIL. "We're witnessing the beginning of a transformative era for cancer screening, with these results demonstrating Galleri's ability to detect cancers earlier, when they can be easier to treat and are potentially curable."
ESMO Data Presentations
Title: Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population: Initial Results from the Registrational PATHFINDER 2 Study
Abstract Number: 7528
Session Title: Proffered Paper session 1: Basic science & Translational research
Date/Time: Saturday, Oct. 18, 2025 at 10:15-10:25 a.m. CEST
Location: Nuremberg Auditorium - Hall 5.2
Title: Clinical Performance of a Blood-only, Targeted Methylation Circulating Tumor DNA (ctDNA) Assay for Minimal Residual Disease (MRD) Detection in Colorectal Cancer (CRC)
Abstract Number: 6215
Presentation Type: e-Poster
EDCC Data Presentations
Title: Long-term cancer registry follow-up of false positive multi-cancer early detection (MCED) test results from the SYMPLIFY study.
Presentation Type: Poster
Title: REFLECTION: Real-World Evidence Study of Multi-Cancer Early Detection (MCED) Among Veterans in the Veterans Affairs Healthcare System (VA)
Presentation Type: Lightning Talk
Date/Time: Thursday, Oct. 23, 10:35-10:50 AM PT
Title: NHS-Galleri trial: approaches to retain a diverse participant cohort across multiple trial appointments
Presentation Type: Poster
Title: Baseline participant characteristics from PATHFINDER 2, a prospective interventional study of a multi-cancer early detection test in a population setting
Presentation Type: Poster
Title: Molecular Cancer Signal Localization in Multi-Cancer Early Detection (MCED) Testing Minimizes Radiation and Imaging Burden Compared to Whole Body Imaging Approaches
Presentation Type: Poster
More information about timing of the EDCC presentations can be found here.
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 Galleri®
The Galleri multi-cancer early detection test is a proactive tool to screen for cancer. With a simple blood test, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer.* The Galleri test approximately doubles the number of cancers detected when added to standard of care screening and has the lowest false positive rate of any MCED test.** When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up. 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.
* The Galleri test performance metrics were derived from the outcomes of an interventional clinical study of patients presenting for screening without clinical suspicion of cancer, a study population that reflects the intended use population.
** Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.
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, include the benefits and use of the Galleri test, the potential of the Galleri MCED test, upcoming events and presentations, expectations about the market for MCED tests and other statements.
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-Q for the period ended June 30, 2025 and our Form 10-K for the period ended December 31, 2024. 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
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