REVEAL GENOMICS® HER2DX® Genomic Test to Be Validated in Pivotal ECOG-ACRIN CompassHER2 pCR Trial in HER2+ Breast Cancer
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/
Contact information
Further information: Adriana Herrera, aherrera@reveal-genomics.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
NIQ and Amazon Marketing Cloud (AMC) Collaborate to Measure Reach and Impact of Cross-Platform Ad Campaigns in Italy21.11.2025 10:00:00 EET | Press release
NIQ and Amazon Marketing Cloud (AMC) have announced a new collaboration to study the effectiveness of cross-platform advertising across linear TV and Amazon Ads inventory in Italy. Through the collaboration advertisers and agencies will gain actionable insights into the relative performance of ad placements across digital, linear TV and streaming environments, including how each contributes to incremental reach and influences product purchases on Amazon’s ecommerce platforms. The insights are made possible by using high-quality data from Sinottica®—a well-established single-source consumer panel in Italy owned by NIQ—with data from Amazon Marketing Cloud. Specifically, the research will leverage Sinottica’s linear TV data alongside several Amazon inventory sources, including Amazon DSP, Sponsored Ads (Products, Brands, Display), and Streaming TV (Prime Video, Twitch, Fire TV). This approach will enable a deeper understanding of how ad exposure across digital and TV channels translates
Ahead of Holiday Season, Visa Identifies Five Transformative Forces Reshaping Global Payment Security20.11.2025 20:50:00 EET | Press release
To celebrate International Fraud Awareness Week, Visa (NYSE: V) today released its Fall 2025 Biannual Threats Report, revealing five forces that are transforming the global payments security landscape. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251120412198/en/ The report, produced by Visa's Payment Ecosystem Risk and Control (PERC) team, draws on intelligence from Visa's global network to identify how criminal operations are evolving with unprecedented speed, scale, and sophistication. "The payments ecosystem is experiencing a paradigm shift in how fraud operates," said Paul Fabara, Chief Risk and Client Services Officer at Visa. "Criminals are no longer working as opportunistic individuals-- they're operating like tech startups, building reusable infrastructure and deploying systematic, industrial-scale operations that challenge conventional defenses. Understanding these evolving forces is critical for the entire ecosy
Suzano Forms Partnership with Tencent and Ecofuturo Institute at COP30 for AI-Powered Conservation and Nature Education20.11.2025 19:25:00 EET | Press release
The world’s largest pulp supplier, Suzano, today announces the signing of a Memorandum of Understanding (MoU) with the multinational technology business Tencent and the Brazilian non-profit Ecofuturo Institute, to pioneer new digital approaches to drive public engagement in conservation. The collaboration will leverage Suzano’s expertise in sustainable forestry, Tencent’s cutting-edge digital technology, and Ecofuturo’s expertise in environmental education, to pilot joint initiatives in both Brazil and China. These include enhancing ecological awareness, accelerating biodiversity solutions, and leveraging digital platforms to foster public engagement in conservation. The partnership will result in a pilot project where advanced AI tools for species recognition developed by Tencent’s Sustainable Social Value organization will be used to identify and monitor native species at Neblinas Park and other conservation areas managed by Ecofuturo. Further initiatives include the development of i
EMVCo Working on How Global Specifications Can Support Agentic Payments20.11.2025 18:38:00 EET | Press release
EMVCo – the technical body that creates and manages EMV® Specifications and programmes that enable seamless and secure card-based payments worldwide – has announced that it is working on how global specifications can support innovation in agentic payment solutions by increasing trust and interoperability across the ecosystem. Agentic commerce is rapidly reshaping the shopping experience by enabling AI agents to act on the consumer’s behalf. This is driving significant momentum for agentic payments, which introduce AI agents as new actors that can initiate transactions with merchants – without requiring direct involvement from the consumer. While agentic payments have the potential to increase convenience and personalisation, they present unique considerations for how transactions are initiated, authenticated and secured. As industry adoption and innovation accelerate, a globally interoperable and scalable approach may be beneficial in realising trusted agentic payments for consumers, m
Andersen Consulting Adds Collaborating Firm Cloud2320.11.2025 16:30:00 EET | Press release
Andersen Consulting enters a Collaboration Agreement with Cloud23, a next-generation consulting firm integrating data and artificial intelligence to drive digital transformation. Located in South Africa, Cloud23 delivers intelligent, platform-based solutions to clients across sectors such as finance, telecom, healthcare, and manufacturing. The firm’s offerings span Salesforce consulting and implementation, managed services, and AI strategy, empowering organizations to modernize customer engagement, optimize operations, and drive measurable outcomes. “Our goal at Cloud23 has always been to simplify transformation through smart, scalable design,” said Ram Ramakrishnan, founder and CEO of Cloud23. “We focus on aligning technology with purpose, delivering outcomes that support long-term growth, customer value, and innovation. Collaborating with Andersen Consulting allows us to amplify our mission and extend the impact of our work across a global platform.” “Cloud23 has achieved impressive
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