REVEAL-GENOMICS-S.L.
14.5.2024 14:06:30 CEST | 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/
About Business Wire
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
Grindr for Equality Commits to Connecting 10M to HIV Prevention by 202827.7.2026 16:31:00 CEST | Press release
New report finds PrEP awareness is high but access is low, as global HIV funding shrinks Grindr steps up Today at the 2026 International AIDS Conference, Grindr for Equality committed to connecting ten million LGBTQ+ people to HIV prevention by 2028, leveraging its platform reach to advance the global effort to end HIV by 2030. The commitment is rooted in Closing the Gap, a new Grindr for Equality report drawing on survey data from Grindr users across ten countries. The central finding is consistent across countries: people know about PrEP but they are not taking it. The barrier is access and the funding that existed to address it is disappearing. "Connecting people is what Grindr does at a scale and in communities that traditional public health systems don't effectively reach," said George Arison, CEO and Chairman of Grindr (NYSE: GRND). "The global HIV response is losing critical funding at the exact moment we should be accelerating to end HIV by 2030. Grindr has the reach and the re
InterSystems Launches Data Studio AI Assistant to Accelerate Enterprise Data Exploration and Insights27.7.2026 16:00:00 CEST | Press release
New Generative AI extension simplifies how teams explore, analyze, and visualize enterprise data InterSystems, a creative data technology provider powering some of the world's most important applications, today announced the general availability of InterSystems Data Studio™ AI Assistant, a new generative AI-powered extension for InterSystems Data Studio that helps organizations more easily understand, navigate, query, and visualize data through natural language interactions. As organizations move from AI experimentation to production deployments, many are discovering that the greatest challenge is not the AI model itself, but providing AI systems with access to trusted, current, and business-ready information. Enterprise data is often fragmented across applications, databases, cloud services, files, data warehouses, and departmental silos, making it difficult for users and AI systems to generate reliable insights. “Organizations are increasingly looking for ways to turn their data into
PMI U.S. Opens $1.2 Billion Aurora Campus, Strengthening U.S. Manufacturing and Export Capabilities27.7.2026 14:00:00 CEST | Press release
Landmark investment advances U.S. manufacturing leadership, creates high-quality jobs, and positions the Colorado location as a strategic production and export hub Philip Morris International Inc.’s (PMI) (NYSE: PM) U.S. businesses (PMI U.S.) today celebrated the opening of its Aurora, Colorado manufacturing campus, a landmark investment representing total capital expenditures of $1.2 billion from 2024-2028. The campus expands the company’s domestic manufacturing capabilities, strengthens supply chain resilience, and positions Aurora as a strategic production and export hub supporting future growth. The site began commercial production in July 2026 and produces ZYN nicotine pouches, joining PMI U.S.’s growing modern nicotine manufacturing network, which includes operations in Owensboro, Kentucky, and Wilson, North Carolina. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727514086/en/ PMI U.S. Opens $1.2 Billion Aurora Cam
Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million27.7.2026 13:20:00 CEST | Press release
Tecnotree, a global leader in AI-native Digital Business Support Systems (BSS) and digital platform solutions, today announced it has secured new digital transformation contracts across Latin America with a combined value of USD 8.8 million, reinforcing the company’s continued commercial momentum and expanding its presence across one of its key strategic growth markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727931342/en/ Tecnotree Strengthens LATAM Growth with New Digital Transformation Contracts Worth USD 8.8 Million Across the engagements, Tecnotree will deploy its AI-native digital platform and B2B Marketplace for enterprises to simplify customer and business operations through intelligent digital engagement, real-time monetization, digital commerce and partner ecosystem management and AI driven marketing and experience management. By providing a unified digital foundation, the platform enables communications
Pure Lithium Corporation Appoints Mercedes-Benz Battery Veteran Dr. Tobias Glossmann as Chief Product Officer27.7.2026 13:00:00 CEST | Press release
Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery company and developer of the patented Brine to Battery™ technology, today announced the appointment of Dr. Tobias Glossmann as Chief Product Officer. In this role, Dr. Glossmann will lead product and technology strategy, guiding the translation of Pure Lithium’s battery science into engineered products and directing the company’s product engineering efforts. Dr. Glossmann joins Pure Lithium after a 25-year career across Mercedes-Benz companies, most recently serving as Principal Systems Engineer at Mercedes-Benz Research & Development North America. His work spanned advanced battery technology development, from materials through complete battery systems, and he held companywide responsibility for high voltage safety. His career began in 2001 with battery systems development at DaimlerChrysler in Ulm, Germany, and later in Michigan, giving him more than two decades of experience across cell chemistry
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