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
Alsym Energy Announces Na-Series Battery Success Developed With Physics-Informed AI Platform27.4.2026 22:25:00 EEST | Press release
Alsym Energy, a pioneer in non-flammable, high-performance sodium-ion batteries, today announced details of the proprietary physics-informed AI platform used to develop the company’s recently launched Na-Series sodium-ion batteries. By integrating fundamental physics models with AI, autonomous testing and proprietary molecular diagnostics in a closed-loop system, Alsym is accelerating the design of safer, inexpensive, commercialized batteries through all phases of the development cycle. As global demand for electricity surges, the limitations of lithium-ion batteries have become increasingly apparent, particularly around safety and supply chain constraints. Lithium-ion chemistry presents inherent challenges, including flammability and reliance on constrained global supply chains—issues that become more acute in large-scale energy storage, where higher energy densities considerably increase fire risks, and growing demand across sectors further strains the supply chain and imperils energ
Backed by Investments Exceeding $1 Billion, PCI Pharma Services Announces Major Expansion of US Sterile Fill-Finish and Drug-Device Delivery Combination Capabilities27.4.2026 17:00:00 EEST | Press release
PCI Pharma Services (“PCI”) – a world-leading integrated global contract development and manufacturing organization (CDMO) focused on innovative biologic and small molecule therapies – announced a series of major infrastructure investments that substantially deepen its sterile fill-finish and advanced drug delivery capabilities. As pharma manufacturers and their development partners increasingly prioritize US supply chain resilience, PCI’s latest investments come as part of a broader commitment exceeding $1 billion across the CDMO’s US and European operations, reinforcing its ability to provide seamless support for drug product development and manufacturing, clinical trial supply and drug-device combination assembly from clinical stages through commercial launch – all underpinned by global capacity, technical expertise, deep scientific knowledge, and an industry-leading quality and regulatory track record. This press release features multimedia. View the full release here: https://www.
Pure Lithium Appoints Renowned Battery Expert Dr. Yuan Gao to Board of Directors27.4.2026 16:53:00 EEST | Press release
Pure Lithium Corporation, a vertically integrated lithium metal battery technology company, is pleased to announce that world-renowned inventor and battery expert Dr. Yuan Gao has joined the company’s Board of Directors. Dr. Gao has been an invaluable member of Pure Lithium’s Scientific Advisory Board since October of 2023. "We are thrilled to have Dr. Gao join our board as we focus on rapidly scaling our technology in the most capital efficient manner possible,” said Pure Lithium Founder, Chairman and CEO Emilie Bodoin. “Dr. Gao is a brilliant scientist who also has deep commercial expertise, a rare combination. He is also unique in the industry because his experience spans the entire battery materials value chain, including all of Pure Lithium’s verticals. His insights over the years have been critical in advancing our technology, and his experience as a director of public companies will strengthen our board.” Dr. Gao commented: “I am thrilled to join the board of Pure Lithium Corpor
Boomi To Unveil the Future Of Data Activation and AI-Driven Innovation at Boomi World 202627.4.2026 16:00:00 EEST | Press release
Boomi, the data activation company, today announced Boomi World 2026, its premier annual user conference, taking place May 11 - 14, 2026 in Chicago, IL. The event will bring together customers, partners, and industry leaders from around the world to explore how data activation is transforming the enterprise and accelerating the path to AI-driven outcomes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427600340/en/ Boomi To Unveil the Future Of Data Activation and AI-Driven Innovation at Boomi World 2026 Boomi World 2026 will spotlight data activation — bringing data to life to power AI, analytics, and intelligent automation. Attendees will gain firsthand insights into how the Boomi Enterprise Platform enables businesses to unify data, streamline operations, and innovate faster in an increasingly agentic world. “Data is only valuable when it’s activated,” said Steve Lucas, Chairman and CEO, Boomi. “At Boomi World 2026, we
Axinn Appoints Rachael Philbin as Chief Innovation Officer27.4.2026 16:00:00 EEST | Press release
Axinn, Veltrop & Harkrider LLP today announced the appointment of Rachael Philbin as Chief Innovation Officer, reinforcing the firm’s continued investment in advanced solutions and technology for legal services delivery. Philbin joins from Proskauer Rose LLP, where she served as Innovation & Transformation Officer. Based in Axinn's New York office, she will lead the firm’s AI and legal technology initiatives as well as knowledge management efforts, accelerating adoption and integration across its antitrust, intellectual property, and litigation practices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260427277725/en/ Rachael Philbin joins Axinn, Veltrop & Harkrider LLP as Chief Innovation Officer. “As Axinn continues to grow, we are making deliberate investments in the capabilities that enable our lawyers to deliver service and results at the highest level in our clients’ complex matters,” said Jeny Maier, managing partner
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