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
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
Verimatrix Launches XTD Velocity Partner Alliance to Accelerate Global Channel Sales19.3.2025 17:45:00 CET | Press Release
Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, today announced the launch of the Verimatrix XTD Velocity Partner Alliance, a global channel sales program designed to empower partners with best-in-class application protection solutions. As part of this initiative, Risk Associates, a leading Managed Security Services Provider (MSSP), has joined the program to offer Verimatrix XTD Enterprise Suite to banks and enterprises across Australia, Bahrain, Saudi Arabia, and the UAE. The XTD Velocity Partner Alliance, spearheaded by Simon Emery, Global Head of Strategic Partnerships at Verimatrix, provides resellers, MSSPs, system integrators, and cybersecurity firms with comprehensive resources to deliver AI-powered mobile app shielding, endpoint threat detection, and response solutions. The program enhances channel sales by offering: Resell XTD & Deliver Managed Services – Offer 24/7 app hardening with AI-drive
Unity Announces Enhanced Engine Performance and Stability, New Platforms, and AI-Powered Workflows at GDC 202519.3.2025 17:00:00 CET | Press Release
GDC – Unity (NYSE: U), the leading platform to create and grow games and interactive experiences, today announced that developers can expect enhanced performance and stability, expanded platform support, and new AI-powered workflows in the three Unity 6 Updates planned for 2025, with the first, Unity 6.1, landing in April. “We don’t want developers to have to choose between stability and new features, or between fidelity and ubiquity. We are committed to delivering it all," said Matt Bromberg, CEO and President of Unity. “Pressure testing new releases in production environments with our partners is enabling much higher quality builds.” Unity 6.1 will enable higher frame rates, smoother gameplay, lower CPU/GPU load for better device performance, and improved debugging for easier optimization. Additionally, Unity is doubling down on its platform reach, extending Unity 6.1’s platform support beyond the current 20+ platforms to include large and foldable Android screens, Meta Quest, Androi
Venture Global Receives Non-FTA Export Authorization for CP2 LNG19.3.2025 15:55:00 CET | Press Release
Today, Venture Global received approval from the U.S. Department of Energy to export liquefied natural gas (LNG) to non-FTA countries for its third project, CP2 LNG, located in Cameron Parish, Louisiana. Venture Global CEO Mike Sabel issued the following statement: “CP2 LNG is a vital project for the U.S. economy, balance of trade, and global energy security. We are grateful for the Trump Administration’s return to regular order and regulatory certainty that will allow us to further expand U.S. LNG exports, which have consistently been found to be in the public interest across multiple Administrations. This will enable us to provide our allies around the world with American LNG in just a few years and for decades to come.” Earlier this month, Venture Global announced that it has launched the FID process for CP2 LNG. To date, the initial phase of CP2 LNG has been sold through 20-year sales and purchase agreements with ExxonMobil, Chevron, JERA, New Fortress Energy, INPEX, China Gas, SEF
Bregal Milestone Announces Strategic Growth Investment in Ridango19.3.2025 15:41:00 CET | Press Release
Bregal Milestone, a leading European software growth private equity firm, today announced a majority strategic growth investment in Ridango, a global provider of mission-critical public transportation software. The investment is made in partnership with founder Erki Lipre and the Ridango management team. Terms of the transaction were not disclosed. Founded in 2009, Ridango is a global market leader in intelligent transportation software for public transport authorities, municipalities, cities, and private transport operators. Ridango has built one of the world’s leading integrated automated fare collection and operations control software platforms, serving more than 150 customers in over 25 countries across five continents. The Company’s modern software provides end-to-end transit management services, from account-based ticketing to contactless bank card acceptance, real-time passenger information, and automatic vehicle location operations management to deliver better transit services,
Stackline and Redslim Partner to Deliver Unparalleled Retail Intelligence and Data Integration for Global Brands19.3.2025 14:00:00 CET | Press Release
Stackline, the leader in retail intelligence and data-driven commerce solutions, has announced a strategic partnership with Redslim, a leading data management company specializing in optimizing syndicated market data. This collaboration provides global CPG and CHC brands with a high-fidelity, 360-degree view of category performance—equipping them to make smarter, faster decisions in an increasingly competitive marketplace. Stackline’s industry-leading solutions provide brands and manufacturers with deep, data-driven insights into category performance. By tracking sales volume, traffic, and conversion rates across the world’s top retail ecosystems, including Amazon, Stackline enables brands to decode the omnichannel shopper journey with precision. Its digital shelf solution delivers advanced analytics to optimize product listings, enhance digital shelf performance, and drive sustained ecommerce growth. Redslim specializes in transforming fragmented market measurement data into harmonize
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