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
Venture Global and Tokyo Gas Announce 20-Year LNG Sales and Purchase Agreement26.11.2025 02:00:00 EET | Press release
Today, Venture Global, Inc. (NYSE: VG) and Tokyo Gas Co., Ltd announced the execution of a new, long-term liquefied natural gas (LNG) Sales and Purchase Agreement (SPA). Under the SPA, Tokyo Gas will procure 1 million tonnes per annum (MTPA) of LNG from Venture Global for 20 years, starting in 2030. This deal marks 7.75MTPA of SPAs signed by Venture Global in the last six months. “With nearly 8 MTPA of new long-term commitments signed this year, Venture Global is pleased to build on our commercial momentum through this new partnership with Tokyo Gas,” said Venture Global CEO Mike Sabel. “Tokyo Gas is a pioneer in the LNG industry and leading provider of natural gas to Japan, and we look forward to working with them as we grow our position as a top LNG supplier to Japan. This agreement will contribute significantly to the US-Japan balance of trade over the duration of the SPA, providing Japan with affordable, reliable American LNG.” About Venture Global Venture Global is an American pro
Airship Study: No-Code Native App Experiences Double Purchase Frequency (+140%), Offering Path to Profitable Holiday Growth26.11.2025 01:08:00 EET | Press release
Mobile-first customer experience company Airship today released new aggregate data analysis findings showing that no-code native app experiences significantly increase conversion for key lifecycle events and more than double purchase frequency. The Airship "Experience Impact” research, which studied over 1,000 in-app retail experiences and 1.7 billion device sessions, quantifies the impact of optimizing end-to-end customer journeys—not just sending messages—using no-code and AI-powered tools to drive loyalty and retention at scale, leading to sustainable profitability in a volatile economic environment. Key Findings Customers exposed to high-impact no-code native app experiences such as optimized onboarding flows, dynamic surveys, or embedded personalized offers, purchase 140% more frequently than app customers who don’t receive them. These experiences, which product owners and marketers can create and adapt without developer resources, significantly increase conversion for key lifecyc
Court Finds That Two Advanced Cell Diagnostics Patents Are Not Infringed by Molecular Instruments’ Proprietary HCR™ RNA-ISH Technology25.11.2025 18:30:00 EET | Press release
Molecular Instruments, Inc. announced today that the Unified Patent Court (UPC) of the European Union has found that Molecular Instruments’ HCR™ RNA-ISH technology does not infringe two patents owned by Advanced Cell Diagnostics, Inc. (a Bio-Techne group company). In a 2024 lawsuit filed in the UPC (proceedings no. UPC CFI 187/2024), Advanced Cell Diagnostics alleged that Molecular Instruments’ HCR™ RNA-ISH technology infringes European patents (EP) 2,500,439 and 1,910,572. The Court in its judgment of 18 November 2025 has rejected that claim and dismissed all of Advanced Cell Diagnostics' lawsuit, ruling that the patents are not infringed either literally or by equivalence (UPC Judgment). This 2025 UPC judgment follows on the heels of an April 2024 UK judgment in which the High Court of England and Wales had already dismissed an earlier infringement lawsuit by revoking the UK parts of the same two Advanced Cell Diagnostics patents (proceedings no. HP-2022-000026), ruling that they wer
Andersen Consulting Bolsters Capabilities with BMA25.11.2025 16:30:00 EET | Press release
Andersen Consulting broadens its sustainability and business transformation capabilities through a Collaboration Agreement with BMA, a South Africa-based firm advancing manufacturing competitiveness and inclusive industrial growth. Established over two decades ago, BMA works across manufacturing value chains—from producers to their clients—alongside government and development agencies to drive sustainable industrial competitiveness. Through its sector-focused industrial clusters, the firm delivers integrated services spanning industrial policy and strategy development, value chain strategy, manufacturing competitiveness and lean consulting, decarbonization and SME development—aligning stakeholders around shared priorities and scalable, long-term solutions. “Sustainable manufacturing goes beyond efficiency. It’s about creating ecosystems that are regenerative, resilient, and strategically aligned with long-term growth,” said Rob Stewart, CEO of BMA. “Many of the organizations we work wi
Pure Lithium Receives Saudi Patent for Vertically Integrated Lithium Metal Battery Technology25.11.2025 15:20:00 EET | Press release
Pure Lithium Corporation, a disruptive lithium metal battery technology company, is pleased to announce that the Kingdom of Saudi Arabia has granted the company a foundational patent titled “Vertically Integrated Pure Lithium Metal Production and Lithium Battery Production.” This broad patent covers technology that combines lithium extraction, anode production and battery manufacturing. Pure Lithium’s Brine to Battery™ is a registered trademark in the Kingdom of Saudi Arabia, planting a strong base of intellectual property in the region. “The technology is particularly relevant to Saudi Arabia because it is one of the places in the world with lithium-containing brines, and even has an abundance of vanadium, which is used in our second-generation battery,” said Founder, Chairman and CEO Emilie Bodoin. “In order to displace today’s lithium-ion battery, our vision is to create global battery hubs with closed loop supply chains, not just in the U.S., but in the many places in the world whe
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