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
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
Pure Lithium Receives Saudi Patent for Vertically Integrated Lithium Metal Battery Technology25.11.2025 15:20:00 EET | Press release
Pure Lithium Corporation, a disruptive lithium metal battery technology company, is pleased to announce that the Kingdom of Saudi Arabia has granted the company a foundational patent titled “Vertically Integrated Pure Lithium Metal Production and Lithium Battery Production.” This broad patent covers technology that combines lithium extraction, anode production and battery manufacturing. Pure Lithium’s Brine to Battery™ is a registered trademark in the Kingdom of Saudi Arabia, planting a strong base of intellectual property in the region. “The technology is particularly relevant to Saudi Arabia because it is one of the places in the world with lithium-containing brines, and even has an abundance of vanadium, which is used in our second-generation battery,” said Founder, Chairman and CEO Emilie Bodoin. “In order to displace today’s lithium-ion battery, our vision is to create global battery hubs with closed loop supply chains, not just in the U.S., but in the many places in the world whe
‘BLUE LOCK - TOKYO EGOIST -’ kicks off on Saturday, November 2225.11.2025 15:07:00 EET | Press release
In its efforts to promote nighttime tourism, the Tokyo Metropolitan Government is developing new attractions that illuminate the capital after dark. As part of this initiative, projection mapping is being presented year-round on the iconic Tokyo Metropolitan Government Building No. 1, transforming its façade into a canvas of light and sound. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251121922505/en/ ©Muneyuki Kaneshiro, Yusuke Nomura, KODANSHA/BLUE LOCK Production Committee. A brand-new production inspired by the internationally popular soccer anime“BLUE LOCK”, titled BLUE LOCK – TOKYO EGOIST –, began screening on Saturday, November 22. On the first day of the screening, a mini-event was held at the Tokyo Metropolitan Government Plaza, where voice actors Kazuki Ura (voice of Yoichi Isagi) and Hiroshi Kamiya (voice of Jinpachi Ego) joined fans in celebrating the premiere. Scenes from the Opening Day of the New Production
Henderson Municipal Power & Light builds multigigabit FTTH network with Adtran fiber access technology25.11.2025 15:00:00 EET | Press release
Adtran today announced that Henderson Municipal Power & Light (HMP&L) is expanding broadband services across Henderson, Kentucky, using its open, intelligent fiber access platform. The highly scalable network leverages Adtran’s AI-powered insights to boost performance and reliability, enabling HMP&L to deliver fast, dependable multigigabit fiber-to-the-home (FTTH) services to residents and businesses. Fully integrated with Mosaic One and GLDS BroadHub® platforms, the solution simplifies network management and elevates the customer experience. The strong partnership between Adtran and HMP&L is enhancing access to digital resources, providing support to local businesses and driving regional economic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251125416908/en/ Adtran’s fiber access technology is helping HMP&L drive multigigabit connectivity to homes and businesses throughout Henderson. “We’re committed to providing t
How Banks and Fintech Will Verify in 2026: Regula Study25.11.2025 15:00:00 EET | Press release
Regula’s report, “What’s Reshaping IDV in Banking & Fintech: 2026 Trends and Predictions,” reveals that biometric verification has become the most attacked point in the digital identity verification (IDV) process across financial organizations. New global data shows that at least three in ten financial institutions are hit by impersonation fraud, driving a shift toward more robust identity verification. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251125171096/en/ Survey data from Regula shows banks and fintechs align on automation and integration challenges, but diverge sharply on user-experience concerns. According to survey data from organizations in the US, UAE, Germany, and Singapore, at least three in ten banks and fintechs report biometric verification as the stage most frequently targeted by fraudsters—ahead of document checks or other onboarding steps. Many of these incidents involve AI-generated media, including
Infineon and HTEC Showcase Humanoid Robotic Head at Infineon’s OktoberTech™ Silicon Valley 2025 Show25.11.2025 15:00:00 EET | Press release
The long-standing collaboration between Infineon Technologies AG and HTEC reached a new milestone this October at OktoberTech™ Silicon Valley 2025, where the two companies presented their jointly developed 360° Awareness Humanoid Robotic Head. The technology, which is a result of close partnership in embedded engineering, sensor fusion, and AI integration, captured the attention of attendees and was honored with the event’s Partner Innovation Award. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251125008456/en/ The Humanoid Robotic Head, developed by HTEC using Infineon technologies, won the Partner Innovation Award at Infineon's OktoberTech event for its innovative 360° multi-sensory awareness and human-interactive robotic capabilities. The Robotic Head represents a major step toward more perceptive and responsive machines. It demonstrates how cutting-edge sensing and processing technologies can enable robots to understand
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