REVEAL GENOMICS® HER2DX® Genomic Test to Be Validated in Pivotal ECOG-ACRIN CompassHER2 pCR Trial in HER2+ Breast Cancer
14.5.2024 15:05:00 EEST | Business Wire | Press release
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
Workiva Advances Regulatory Work with AI Innovation15.9.2026 18:00:00 EEST | Press release
Workiva Inc. (NYSE: WK), a leading, audit-ready platform for trust, transparency, and accountability, unveiled dozens of new product and platform innovations at Amplify 2026, the company’s annual conference attended by thousands of finance, accounting, sustainability, risk, and compliance leaders. Workiva Debuts Agent Studio Workiva introduced Agent Studio, a landmark platform capability that empowers users to quickly build, customize, and deploy AI agents in Workiva's trusted platform. By combining AI reasoning with Workiva's native platform capabilities, enterprise knowledge, and governed workflows, Agent Studio enables users to automate sophisticated manual business processes without writing any code. Organizations can enrich agents with company-specific knowledge and context, tailor them to their own processes, and schedule automations to execute recurring work. “With Agent Studio, we're putting the power to build in the hands of the people who know the work and their company the b
Study: Heatwaves Increase Cough Urge, Which Salt Aerosols Reduce15.9.2026 16:15:00 EEST | Press release
SC Therapeutics, with University North Carolina, Imperial College London, and Boston University, announced publication on Tuesday in Nature Scientific Reports of results from a multi-institutional study indicating that the aridity inherent in heatwaves increases cough hypersensitivity in human airways by collapsing mucus onto cilia in a manner common to chronic respiratory diseases, such as cystic fibrosis, and asthma. The researchers find that alkaline aerosols of magnesium salts reverse mucosal collapse for several hours, and reduce cough hypersensitivity as reflected in placebo-adjusted suppression of daily cough bout rate (59%, p=0.03) and persistence of suppression post treatment for 1 to 3 weeks in a randomized, double-blind, placebo-controlled study of 10 refractory chronic cough patients. “Paris recorded 5,764 excess deaths between 17 June and 2 July, a period of time during which we report atmospheric aridity in the city increased approximately 3-fold relative to the 35 year a
ADM’s Fourth Annual Regenerative Agriculture Report Highlights Growing Resilience Across the Food System15.9.2026 16:00:00 EEST | Press release
ADM (NYSE: ADM), a global leader in innovative solutions from nature, today released its fourth annual regenerative agriculture report, showing how its programs are supporting farmers, strengthening agricultural supply chains and delivering measurable environmental outcomes around the world. “Resilience starts on the farm. By improving and protecting soil health, farmers can be better equipped to adapt to changing conditions and maintain productive operations,” said Greg Morris, SVP and President, Ag Services and Oilseeds, ADM. “That resilience can extend across the value chain, helping strengthen the food system we all depend on.” In 2025, ADM’s regenerative agriculture programs engaged more than 56,000 farmers across approximately 4.6 million acres, 11 countries and 10 crops. Compared with regional benchmarks, the programs resulted in approximately 946,000 metric tons of CO₂e reductions. “ADM views agriculture as a powerful way to meet evolving customer needs, and our work in regener
Diligent Unveils New Agentic Capabilities in Diligent One to Power the Future of Governance, Risk and Compliance15.9.2026 16:00:00 EEST | Press release
Diligent, the AI leader in governance, risk and compliance (GRC) solutions, today announced a major enhancement to Diligent One, its native AI platform, at Gartner’s Enterprise Risk, Audit and Compliance Conference (ERAC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915941016/en/ “For many organizations, GRC work is slowed by fragmented systems, manual coordination and time-consuming reporting processes,” said Brian Stafford, President and CEO of Diligent. “Our latest agentic capabilities help teams cut through that complexity by connecting context, surfacing what matters and driving faster execution — while keeping governance and professional judgement at the center." An orchestration agent that coordinates work and approvals The orchestration agent in Diligent One gives GRC professionals a natural-language interface to coordinate audit and risk work. Instead of simply answering questions, it enables users to describe
Unifocus Launches AI-Powered Platform to Transform Workforce and Operations Management in Hospitality15.9.2026 16:00:00 EEST | Press release
The global hospitality technology provider, Unifocus, has announced the launch of its newest AI platform, Unifocus Claira. Unifocus Claira is an industry first end-to-end workforce management and operations platform, purpose-built to give hoteliers and above-property hospitality organizations complete visibility across the workforce lifecycle through one cohesive system. By replacing the patchwork of disconnected tools, multiple technology stacks and siloed data systems that have traditionally been used to manage labor and operations processes, Unifocus Claira delivers one connected AI-native platform, providing customers with a comprehensive and organized view of their workforce and operations data. This unified data foundation powers advanced AI capabilities designed to accelerate decision-making, improve operational performance and drive business growth. Importantly, Unifocus Claira is also the first end-to-end platform of its calibre, purpose-built specifically for the select servi
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