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
GTN and Solidus Labs Announce Landmark Surveillance Partnership23.9.2026 16:00:00 EEST | Press release
GTN, the global fintech, and Solidus Labs, the category-definer in multidimensional market integrity, today announced a landmark partnership that deploys Solidus Labs' HALO platform across GTN's operations. Under the partnership, HALO is deployed across GTN's global order book, delivering integrated trade surveillance and transaction monitoring across equities, fixed income, derivatives, FX and digital/crypto assets. This means for brokers, banks, asset managers and fintechs, the era of surveillance as a barrier to market participation is over. Beyond GTN's internal compliance operations, this partnership introduces a surveillance layer that lets GTN's 500+ clients access dedicated HALO tenants through GTN's infrastructure. This embeds institutional-grade surveillance capabilities into the infrastructure that those firms already run their business on. Rather than each client independently procuring, integrating and running a surveillance stack, GTN's model lets firms across its institu
SS&C Technologies Unveils Portfolio of AI-Enabled Enhancements; Debuts Six-Part Agentic Blueprint Docuseries at SS&C Deliver23.9.2026 16:00:00 EEST | Press release
SS&C Technologies Holdings, Inc. (Nasdaq: SSNC) today unveiled a suite of next-generation solutions at its annual SS&C Deliver 2026 conference. More than 1,100 leaders from the financial services and healthcare industries gathered in Orlando, Florida, to learn how SS&C is optimizing business workflows with AI-enabled services. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923521682/en/ A core technology set spanning wealth, retirement, alternatives and asset management is built on the SS&C AI Gateway governance platform. SS&C WorkHQ, the company’s award-winning agentic orchestration platform, enables interoperability across these solutions. SS&C also debuted the six-part The Blueprint: Customer Zero docuseries, a behind-the-scenes look at how SS&C is running the same agentic transformation it is now bringing to its 23,000 clients. "Agentic AI is challenging enterprises. The technology moves fast, the governance stakes ar
Corient Expands to Cayman Islands with Acquisition of FortCay Family Office Advisory23.9.2026 16:00:00 EEST | Press release
Corient, the world’s largest multi-family office and non-bank wealth manager focused on ultra-high-net-worth and high-net-worth clients, today announced the addition of FortCay Family Advisory (“FortCay”), a Cayman Islands wealth manager and multi-family office. FortCay, founded by Billy Harty and Matt Houghton, serves 14 ultra-high-net-worth families representing approximately US$2.6 billion in client assets, providing comprehensive wealth management, estate planning and family office services. The acquisition establishes Corient in the Cayman Islands, a leading international financial center and important hub for private wealth, extending the firm’s reach in a strategically important market. “A meaningful share of the world’s most complex family wealth is structured and administered in the Cayman Islands,” said Kurt MacAlpine, Founding Partner and Chief Executive Officer of Corient. “Many of our clients live, work, and invest across borders – establishing a presence in Cayman deepens
Principal Asset Management ® and Longevity Partners Launch REsponsible Asset Solutions to Scale Real Estate Decarbonization Strategies23.9.2026 16:00:00 EEST | Press release
Principal Asset Management® and Longevity Partners today announced the launch of REsponsible Asset Solutions (RAS), a new platform designed to help institutional real estate owners identify, underwrite, and execute decarbonization initiatives that improve building performance, reduce energy consumption and enhance long-term asset value while meeting investment return objectives. REsponsible Asset Solutions brings together the institutional investment expertise of Principal Asset Management's dedicated real estate platform, a top-10 global real estate manager1 with $108 billion in assets under management2 and more than 65 years of experience, and Longevity Partners' engineering, procurement, and implementation capabilities. By combining deep real estate investment knowledge with technical decarbonization expertise, RAS provides scalable, value-enhancing strategies that help clients advance sustainability objectives while supporting long-term asset value. “Many institutional investors ha
The Estée Lauder Companies and the Breast Cancer Research Foundation Launch Largest Global Research Initiative on Breast Cancer in Younger Women23.9.2026 15:30:00 EEST | Press release
The Estée Lauder Companies today announced a new five-year commitment to the Breast Cancer Research Foundation to establish the Global Research Initiative on Breast Cancer in Younger Women. This first-of-its-kind research coalition will address the alarming global rise in breast cancer diagnoses among younger women, building on more than three decades of partnership between The Estée Lauder Companies and the Breast Cancer Research Foundation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923337773/en/ The $15 millioncommitment from The Estée Lauder Companies Charitable Foundation is designed to confront an urgent and significantly underfunded need. Diagnoses among women under age 45 increased by 11 percent from 2012 to 2022,1 while an estimated only 0.6 percent of breast cancer research funding since 2020 has focused on younger women. Breast cancer in younger women is more likely to be diagnosed at a later stage and to b
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