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
DDN Selected to Modernize Research Data Infrastructure at UNSW Sydney26.10.2026 23:30:00 EET | Press release
DDN, the global leader in AI and data intelligence solutions, today announced that UNSW Sydney has selected DDN to deliver a new research data storage environment as part of the university’s Research Data Experience (RDE) program. Working with Australian software company Arcitecta, DDN will combine its EXAScaler parallel file system with Arcitecta’s Mediaflux® data management platform to help researchers spend less time managing data and more time using it. Following an extensive 18-month evaluation, UNSW selected an integrated approach that will replace 11 legacy storage systems with a coordinated environment for high-performance storage and enterprise data management. The decision reflects a broader challenge facing research-intensive institutions: how to support rapidly expanding scientific datasets while simplifying infrastructure, improving data accessibility and managing long-term costs. Built for data-intensive research, high-performance computing and AI workloads, DDN EXAScaler
Agent Assurance by TestMu AI Is Now Generally Available, Letting Teams Test What Their AI Agents Actually Change26.10.2026 17:15:00 EET | Press release
TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, today announced the general availability of Agent Assurance. Agent Assurance tests AI agents that take actions, such as calling tools, writing files, and changing records, by checking what a run actually changed rather than what the agent says it did. Any team can now create a TestMu AI account and run it against its own agent without booking a demo first. Agent Assurance launched on August 17, 2026, behind a waitlist and a guided onboarding session. Since then, Rook, the CLI that runs Agent Assurance, has shipped a steady run of releases, shaped by feedback from early teams. Agent evaluation has mostly graded the final reply, and that reply can be wrong about the agent's own work. In CXBench, a benchmark of LLM agents in regulated customer-experience workflows published in October 2026, 80.1% of runs that reached the right outcome still failed the process checks, and only 13.8% passed b
Actiphy Announces ImageServer for Centralized Backup Storage and Post-Backup Processing26.10.2026 17:13:00 EET | Press release
Actiphy™, Inc., a provider of backup, disaster recovery, and virtualization software, today announced Actiphy ImageServer™, a centralized platform for storing, managing, verifying, and replicating backups created with ActiveImage Protector™. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026410729/en/ Actiphy ImageServer Console ImageServer combines the management capabilities of Actiphy ImageCenter™ with the secure storage of Actiphy StorageServer™. By moving Verify, Replication, Consolidation, and BootCheck™ to a dedicated server, ImageServer reduces processing load on protected systems and simplifies backup administration. As organizations protect more systems and retain more backup generations, storage and administrative demands grow. ImageServer addresses these challenges by centralizing backup storage and management and automating post-backup processing. Key capabilities include: Inter-File Deduplication™ — Identifi
Dubai Chambers Launches World's First Agentic AI Marketplace by a Chamber of Commerce26.10.2026 17:06:00 EET | Press release
Dubai Chambers has launched Chamber AI Hub, the world's first Agentic AI marketplace developed by a chamber of commerce, enabling businesses in Dubai to access ready-to-use AI agents that independently perform a range of administrative and operational tasks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026467531/en/ H.E. Sultan bin Saeed Al Mansoori Chairman of Dubai Chambers. (Photo: AETOSWire) The marketplace currently offers 22 specialised AI agents across seven business functions including Compliance, Procurement, Operations, Finance, Sales, Human Resources, and Logistics. The offering is set to expand to 100 agents. The initiative supports Dubai's efforts to accelerate the adoption of Agentic AI across the private sector, helping businesses enhance efficiency, strengthen competitiveness, and transform their operating models. H.E. Eng. Sultan bin Saeed Al Mansoori, Chairman of Dubai Chambers, commented: “Success in
Media Release: Allianz Beach Arena for the LA28 Olympic and Paralympic Games Joins the Allianz Family of Stadiums26.10.2026 16:37:00 EET | Press release
For the first time in Olympic and Paralympic history, a competition venue will carry the Allianz name. The Allianz Beach Arena in Long Beach, California, for the LA28 Olympic and Paralympic Games will become the newest member of the Allianz Family of Stadiums. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026919959/en/ Allianz's "custom A" emblem for LA28. From Horse Guards Parade in London to Copacabana Beach in Rio and the Eiffel Tower in Paris, Olympic Beach Volleyball has always found its home in iconic settings around the world. At the LA28 Games, that home will carry the Allianz name. Allianz is proud to help celebrate this exciting sport in Long Beach, a city in the southern part of Los Angeles County where beach volleyball is part of everyday life and local culture. Set right on the Long Beach waterfront, the nearly 15,000 seat temporary arena will host the Olympic Beach Volleyball and the Paralympic Blind Footba
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