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
mimik Operationalizes Agentic AI on the AMD Ryzen™ AI Embedded X100 Series23.7.2026 21:30:00 EEST | Press release
mimik today announced mimOE™ Embedded Edition, a package of its Agentix Operating Engine and a set of purpose-built tools for the AMD Ryzen™ AI Embedded X100 Series processor, the newest processor in a family designed for physical AI, autonomous systems, and industrial automation. Available to download today, mimOE Embedded Edition gives OEMs, tier-1 suppliers, system integrators, and agent developers the path to operationalize Agentix-Native systems (aka Agentic AI), in which autonomous agents can reason, coordinate, and act directly on devices, from PoC to scaled operations with certainty. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260723555565/en/ Agentic AI operations are both CPU and GPU bound. Enterprises can now scale with certainty. Generative AI has centered on the GPU. Agentix-Native systems must spread the work. In a real multi-agent workflow traced by mimik, more than 80 percent of operations were CPU work: d
U.S. Federal Court Permanently Bans 19 Online Sellers of Fake Urolithin A Supplements and Awards $5.3 Million in Damages to Timeline23.7.2026 17:27:00 EEST | Press release
Timeline (Amazentis SA), the Swiss life-sciences company that pioneered the postbiotic ingredient Urolithin A and its branded form Mitopure®, together with its U.S. subsidiary Timeline Longevity, Inc., announced today that the U.S. District Court for the District of Massachusetts has granted the companies’ motion for default judgments and permanent injunctions against 19 online sellers found to have marketed and sold nutritional supplements falsely advertised as containing Urolithin A. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722951066/en/ Timeline longevity supplement powered by Mitopure; proprietary, highly pure Urolithin A. The order, entered July 15, 2026 by Judge Myong J. Joun in Amazentis SA et al. v. The Partnerships and Unincorporated Associations Identified on Schedule “A”, Case No. 1:25-cv-12913-MJJ (District of Massachusetts), permanently enjoins 19 defaulting defendants from further manufacturing, market
TestMu AI Introduces the Source-to-Verdict Loop in Kane CLI, Carrying Every Requirement to a Ship Decision With Portable Proof23.7.2026 16:45:00 EEST | Press release
TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, introduced a source-to-verdict loop in Kane CLI, its natural-language testing tool. Building on Kane CLI's evolution from a browser automation tool, the loop carries a product requirement to a ship decision, writing the tests, running them in the local browser, collecting the proof, measuring coverage from what actually happened, and returning a verdict. As AI agents write, run, and fix tests, a green checkmark is no longer enough: a step that checks nothing passes, a test written against a spec that changed weeks ago passes, and an agent that says “done” without the click ever landing passes. Empty green and earned green are the same color on every dashboard, the number climbs while the risk does not move. Kane CLI closes that gap: it carries a requirement to a verdict, and proves every step of it. One loop. Source to verdict. You no longer hand Kane CLI a test script, you hand it your
Norway’s health system adopts Wolters Kluwer UpToDate Enterprise Edition23.7.2026 16:30:00 EEST | Press release
Wolters Kluwer Health announced that Norway’s health system has renewed its adoption of UpToDate Enterprise Edition, a market-leading Clinical Decision Support (CDS) solution, for its nationwide health system which includes over 50 public hospitals and 11,000 beds in over 20 trusts. This extends a 15 year partnership with Helsebiblioteket, now part of the Norwegian Institute of Public Health (NIPH). Helping clinicians on a national scale Kjell Tjensvoll, Team Leader for Helsebiblioteket said, ‘‘Providing frontline teams with easy access to the latest medical knowledge is vital in reducing unwarranted variation and improving patient care on a national scale. UpToDate Enterprise Edition enables this, and we are delighted to strengthen our relationship with Wolters Kluwer and provide continued support for clinicians across the country.’’ UpToDate Enterprise Edition was selected by Helsebiblioteket, the Norwegian Electronic Health Library. The selection followed a competitive process by th
Boyd Watterson Global Names John Creswell Global Chief Client Officer to Accelerate Global Growth and Client Engagement23.7.2026 16:00:00 EEST | Press release
Boyd Watterson Global today announced the appointment of John Creswell as Global Chief Client Officer, a newly created senior leadership role that reflects the firm's continued investment in growth and its evolution into a leading global alternatives investment platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722823117/en/ John Creswell has joined Boyd Watterson Global as Global Chief Client Officer, a newly created role overseeing global sales, client engagement and marketing across the U.S., Europe and APAC. In this role, Creswell will oversee global sales, client engagement and marketing efforts across the United States, Europe and APAC, helping investors access the firm's capabilities while strengthening relationships with institutional and private capital partners worldwide. While based in Chicago, John will spend considerable time at the firm’s headquarters in Cleveland as well as in key offices globally. Cr
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