REVEAL-GENOMICS-S.L.
REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, today announced the forthcoming prospective validation of its groundbreaking diagnostic tool HER2DX® within the framework of the ongoing CompassHER2 pCR Trial. This study is led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN), a scientific organization that designs and conducts cancer research involving adults who have or are at risk of developing cancer, comprising nearly 1400 member institutions in the United States and around the world.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240509117263/en/
The CompassHER2 pCR Trial (also EA1181) is a single-arm phase II neoadjuvant study that successfully enrolled 2175 patients with stage II or IIIa HER2-positive (HER2+) breast cancer. Now in follow-up, this trial seeks to determine if it is safe to omit adjuvant chemotherapy after surgery for patients with a pathologic complete response (pCR) after 3 months of pre-operative treatment with standard THP (single-agent taxane chemotherapy plus trastuzumab and pertuzumab [HP], both targeted drugs). If testing shows pCR at the time of surgery, patients will then complete a year of HP plus hormonal therapy and radiation, if indicated.
If the study's results validate this approach, it would allow patients to have fewer side effects and better quality of life. The neoadjuvant setting offers the opportunity to use pCR as a functional biomarker to identify patients with excellent outcomes and refine treatment to maximize benefit and minimize toxicity. The primary objective of the trial is 3-year recurrence-free survival, and pCR is a secondary endpoint.
In this collaboration, the CompassHER2 pCR Trial protocol has been amended to include the evaluation of the HER2DX® genomic test as a key secondary correlative endpoint. HER2DX® pCR-score and HER2DX® risk-score will be analyzed in baseline pre-treatment samples from most trial participants, linking these scores directly to patient outcomes.
The principal investigator of the CompassHER2 pCR Trial, Dr. Nadine M. Tung, commented, "Integrating HER2DX®'s predictive capabilities into our trial represents a significant opportunity in our quest to tailor treatments to the individual, not just the cancer type. If proven and validated, this assay could fundamentally change our approach to treating HER2-positive breast cancer."
Previous retrospective validation involving 765 patients with early-stage HER2+ breast cancer who received neoadjuvant therapy highlighted the HER2DX® pCR-score's ability to distinguish patients with a high pCR rate of 80-90% after treatment with single taxane, trastuzumab, and pertuzumab.
REVEAL GENOMICS' CEO, Patricia Villagrasa, added, "The inclusion of HER2DX® in the CompassHER2 pCR Trial is a testament to our commitment to advancing breast cancer treatment. By providing a more nuanced understanding of HER2-positive cancers, HER2DX® will play a crucial role in shaping the future of personalized therapy and improving patient outcomes."
HER2DX® in the CompassHER2 pCR Trial: Guiding the way to personalized medicine
The inclusion of HER2DX® in the CompassHER2 pCR Trial seeks to corroborate these initial findings, providing Level 1 evidence to support the selection of an optimized therapy regimen. Specifically, it seeks to validate the use of a single taxane-based regimen over traditional multi-agent chemotherapy, potentially revolutionizing the treatment approach for HER2-positive breast cancer by enabling more personalized, less intensive treatment strategies.
This pivotal collaboration represents a significant step towards personalized medicine in the management of early-stage HER2-positive breast cancer.
About HER2DX®️
HER2DX®️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS®️ since January 2022, HER2DX® is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.
HER2DX®️ is a prognostic, predictive assay based on clinical and genomic data. The test integrates clinical information (i.e. tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene.
HER2DX®️ predicts:
- Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.
- pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.
- ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.
About ECOG-ACRIN
ECOG-ACRIN is renowned for advancing precision medicine and biomarker research through its leadership of major clinical trials that integrate cutting-edge genomic approaches. Through the CompassHER2 (COMprehensive use of Pathologic response ASSessment to escalate or de-escalate therapy in HER2-positive breast cancer) Trial Program, ECOG-ACRIN is collaborating with the Alliance for Clinical Trials in Oncology to investigate the optimization of therapy in patients with HER2+ breast cancer. The CompassHER2 pCR Trial (NCT04266249) was the first to open in this program, funded by the National Cancer Institute, part of the US National Institutes of Health.
Web: www.ecog-acrin.org, X: @eaonc. Other: Facebook, LinkedIn, and Instagram.
About REVEAL GENOMICS®️
REVEAL GENOMICS, S.L. is a biotechnology start-up seeking to change the way biomarkers are used in oncology. It is focused on developing innovative diagnostic tools to define the best therapeutic options for patients with cancer. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.
REVEAL GENOMICS, S.L. is a spin-off company of Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona (U.B.), and Vall d’Hebron Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L.
Web: www.reveal-genomics.com. X: @revealgenomics
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240509117263/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Doha Debates Explores the Role of Ancient Wisdom in Today’s World5.11.2025 16:06:00 CET | Press release
Experts and students debate whether ancient wisdom holds answers for modern societies As the world grapples with questions of meaning and moral direction, Doha Debates takes on a fundamental question: Should ancient wisdom guide today’s societies? This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105183709/en/ Guest speakers and participating students gather on the Doha Debates stage to discuss a fundamental question “Should ancient wisdom guide today’s societies?” — part of the show’s exploration of timeless questions shaping our world today. (Photo: AETOSWire) In this episode of the new flagship season, moderated by Dareen Abughaida, students from across Qatar join three global thinkers to wrestle with a timeless dilemma: whether the answers to our most pressing problems lie in tradition or in bold new ideas. Wael Hallaq, Avalon Foundation Professor in the Humanities at Columbia University, critiques what he calls the “mor
Versa Delivers Proven Firewall Performance and Security Effectiveness Validated by Independent Testing5.11.2025 15:30:00 CET | Press release
Versa One of Only Three Recommended Products, Maintaining Position as Performance Leader by Delivering Fastest Throughput While Achieving a 99.43% Security Effectiveness Score Versa, the global leader in unified networking and security, today announced that its Next-Generation Firewall received CyberRatings.org’s highest “Recommended” rating for the ninth consecutive year. In the newly published Q3 2025 Enterprise Firewall report, based on independent testing by NSS Labs, Versa delivered 100% scores in critical categories like malware and exploit evasion resistance, and achieved a leading 7,626 Mbps rated throughput, over twice as fast as competing solutions. Selecting cybersecurity solutions requires unbiased, real-world performance testing and evaluation. CyberRatings.org provides IT and security leaders with data-driven results to guide investment decisions. In this latest assessment, Versa ranked among the top three vendors for Security Effectiveness and delivered more than twice t
Its Global Vision on Show, TVS Motor Company Makes a Stellar Debut at EICMA5.11.2025 15:16:00 CET | Press release
Six new products - a resurgent “new Norton”, connected technology, AR based Heads-Up Display Helmets, new range of accessories and a roadmap for Europe - underline TVSM’s presence at the world’s largest 2-wheeler exhibition. TVS Motor Company (TVSM) - a global leader in two and three-wheeler manufacturing - has taken centerstage at EICMA 2025, making a landmark debut at the world’s largest motorcycle exhibition. With a show floor commanding presence, TVS unveiled 6 new products across ICE and thermal powertrains, advanced ride assist gear including AR based Heads-Up display helmets, a stunning new range of accessories, connected technology that enhances rider-machine connect and its roadmap for expansion in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105242034/en/ TVS top leadership team posing with the global showcases at EICMA. From L to R: TVS M1-S, TVS X, TVS eFX three O, TVS RTX 300 and RTX 300 BTO, TVS Ta
Car Connectivity Consortium Releases Inaugural Industry Report on Global Vehicle Connectivity Trends5.11.2025 15:00:00 CET | Press release
60% of industry leaders cite security and ease of use as top priorities in CCC’s new report highlighting global trends and innovation across the connected vehicle ecosystem The Car Connectivity Consortium® (CCC), the trusted source for defining how vehicles interact with devices and the world to enhance the consumer experience through standardized, secure, and convenient connectivity solutions, today released its 2025 Future of Vehicle Connectivity Report. The findings reveal how automakers, suppliers, and technology providers across regions are aligning around secure, seamless connectivity as a foundation for innovation. With Deloitte projecting the value of software-defined vehicles to reach up to $600 billion by 2030, the connected vehicle market is entering a new phase of growth. To better understand how the industry is preparing for this evolution, the CCC surveyed its membership to uncover where companies are investing and focusing their attention. CCC’s more than 300 member comp
Rimini Street Announces Upcoming 2025 Investor Events Schedule5.11.2025 15:00:00 CET | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced the following upcoming 2025 Investor Events Schedule. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105382959/en/ Rimini Street Announces Upcoming 2025 Investor Events Schedule Investor Conferences: Michael L. Perica, chief financial officer and Dean Pohl, vice president, treasurer and investor relations, will be meeting with investors one-on-one and in small group meetings at the following Investor Conferences. November 18, 2025: Craig-Hallum 16th Annual Alpha Select Conference, NYC November 19, 2025: Roth Capital 14th Annual Technology, NYC Rimini Street Investor Day 2025: In addition, join CEO, Seth Ravin and his Senior Executive Team who will share their vision, strate
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom