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
Social Development Bank Highlights Strategic Partnerships and Global Initiatives at DeveGo 202524.12.2025 18:27:00 EET | Press release
The Social Development Bank (SDB) hosted the second edition of the Entrepreneurship and Modern Business Practices Forum, “DeveGo 2025”, from 21 to 23 December in Riyadh. Held under the patronage of His Excellency Eng. Ahmed bin Sulaiman Al Rajhi, Minister of Human Resources and Social Development and Chairman of SDB’s Board of Directors, the forum brings together government leaders, global experts, investors, and entrepreneurs to shape the future of entrepreneurship and modern business practices in the Kingdom of Saudi Arabia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251224036724/en/ From right to left: Ahmed Al Rajhi, Saudi's Minister of Human Resources and Social Development, H.E. Rebeca Grynspan, Secretary-General of UNCTAD, and Sultan Al Hamidi, CEO of Social Development (Photo: AETOSWire) Opening the forum, Minister Al Rajhi delivered a keynote speech on the growing vibrancy of Saudi Arabia’s entrepreneurial movem
Making Science Unveils ‘AWAKE’: The AI Venture Studio Industrialising Startup Creation and AI-First Innovative Solutions23.12.2025 21:51:00 EET | Press release
Making Science, the global digital acceleration consultancy, today announced the launch of AWAKE Venture Studio. This "AI-first" model represents a new era in systematic innovation, designed to identify, prototype, and scale both internal proprietary solutions and independent AI-native startups with global reach. The launch of AWAKE is motivated by the significant efficiency gains of orders of magnitude that Making Science has already achieved through the internal integration of AI. By applying these methods, the firm has achieved a 2x acceleration in tech feature development reducing time in the deployment of AI Agents. This model has already proven its commercial and innovative power through the acceleration of startups like ad-machina, which has multiplied its value by 10 since joining the Making Science ecosystem. These proven benchmarks serve as the technical foundation for AWAKE’s two interconnected engines, which formalise this efficiency into a repeatable manufacturing process
FDA Clears First Extended Depth of Focus Contact Lens for Presbyopia23.12.2025 19:07:00 EET | Press release
The Cataltheia Group and its U.S. subsidiary, Bruno Vision Care LLC, a leader in eye health innovation, today announced that the U.S. Food and Drug Administration (FDA) has cleared the first and only Daily Disposable Soft (Hydrophilic) Contact Lens for Presbyopia utilizing patented Extended Depth of Focus (EDOF) optical design technology, enabling commercial distribution in the United States. Deseyne® delivers smooth, continuous focus across near, intermediate, and distance vision, providing clear, natural vision without compromise. This performance is enabled by Cataltheia’s patented hyper-refractive central zone, engineered to precisely redirect light in a controlled manner. The result is a clear clinical advantage over the only other available contact lens option for presbyopia, multifocal lenses, which rely on multiple optical zones and often require prolonged visual and cognitive adaptation. “We are proud to offer the first contact lens solution for the world’s aging population th
Aramco Awards SLB Long-Term Contract to Support Kingdom’s Unconventional Gas Production Growth23.12.2025 15:58:00 EET | Press release
Global technology company SLB (NYSE: SLB) has been awarded a five-year contract by Aramco to provide stimulation services for its unconventional gas fields. This award is part of a broader multi-billion contract, supporting one of the largest unconventional gas development programs globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251223074948/en/ The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources. The contract encompasses advanced stimulation, well intervention, frac automation, and digital solutions, which are important to unlocking the potential of Saudi Arabia’s unconventional gas resources — a cornerstone of the Kingdom’s strategy to diversify its energy portfolio and support the global energy transition. “This agreement is an important step forward in Aramco’s effor
Tabelog, Japan's Largest (*1) Restaurant Search and Reservation Service, Launches Multilingual App for International Visitors23.12.2025 15:00:00 EET | Press release
Tabelog (https://tabelog.com/en/), Japan's largest restaurant search and reservation service operated by Kakaku.com, Inc., launched its multilingual smartphone application (iOS/Android) for international travelers on Monday, November 17, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251221963753/en/ The Tabelog Multilingual App for International Travelers — Japan's Largest Restaurant Search and Reservation Service With approximately 100 million monthly users(*3), Tabelog is Japan's premier service widely used by Japanese locals for daily restaurant discovery. Its database is unrivaled domestically, featuring information on approximately 890,000 establishments nationwide and over 85 million reviews and photos(*4). Unlike global map services or travel sites, Tabelog is built on "authentic ratings and reviews from local Japanese users," enabling travelers to discover truly exceptional restaurants beloved by locals — not
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