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
STOKR Appoints Subhankar Sinha as Senior Advisor23.3.2026 15:00:00 CET | Press release
Former BNY and PwC blockchain leader appointed to advance fund tokenization and STOKR's U.S. institutional expansion STOKR has appointed Subhankar Sinha as Senior Advisor. Sinha will work directly with STOKR's leadership team on fund tokenization with particular focus on money market fund (MMF) tokenization and on expanding STOKR's institutional presence in the U.S. market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323315236/en/ Image, Subhankar Sinha A New York-based digital assets executive, Sinha brings deep expertise across blockchain infrastructure, capital markets, and institutional business development. He previously served as Head of Blockchain at BNY, the world's largest custody and asset servicing business. Earlier in his career, he was a Director at PwC, where he co-founded and co-led the firm's blockchain consulting practice in the U.S. "Subhankar brings the institutional depth that this stage of STOKR's
Xsolla Partners With Cyprus Game Makers Association (CYGMA) as the Island Emerges as a Game Development Hub23.3.2026 14:00:00 CET | Press release
Strategic Partnership Equips Cyprus-Based Developers With the Commerce Infrastructure to Compete Globally Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announced a strategic partnership with the Cyprus Game Makers Association (CYGMA). The collaboration will provide creators and studios within the CYGMA network with hands-on support, industry expertise, and access to world-class commerce tools, helping Cyprus-based studios bring their titles to players worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323570679/en/ Graphic: Xsolla The partnership comes as Cyprus continues to attract game development talent, fueled by favorable business conditions and a growing creative community. Through its collaboration with CYGMA, Xsolla aims to accelerate momentum and expand opportunities for developers by removing commerce and distribution barriers that often p
Exein Unveils Next-Generation Runtime Security to Protect the AI-Native World23.3.2026 14:00:00 CET | Press release
Photon blocks cyberattacks before execution across physical AI and IoT, autonomous AI agents and cloud and edge infrastructure Kernel-level prevention sets a new standard beyond traditional user-space detection Builds on Exein’s position as the world’s largest runtime security provider, protecting over two billion devices Exein, the global leader in runtime cybersecurity, today unveiled Photon, a preemptive breakthrough solution that blocks cyberattacks at the point of execution. Designed for the AI-native world - where digital and physical systems are now inseparable - Photon marks a fundamental shift in how critical infrastructure protects itself. Unlike traditional cybersecurity solutions that detect threats after compromise - typically operating in user space and relying on a cloud network - Exein’s Photon operates directly inside the kernel, preventing malicious execution paths before they can run. By blocking attacks before the point of execution, the technology dramatically redu
Manhattan Associates’ 2026 Unified Commerce Benchmark Reveals the High Price of Standing Still in Retail23.3.2026 13:30:00 CET | Press release
Leaders achieve up to 2X revenue growth, but only 7% of retailers are true unified commerce leaders Manhattan Associates Inc. (NASDAQ: MANH), today announced the findings of its 2026 Global Unified Commerce Benchmark for Specialty Retail, the industry’s most comprehensive assessment of how well retailers connect digital and physical experiences to drive growth, profitability and loyalty. Conducted by Incisiv, a leading retail research firm, the Benchmark is based on real-world purchases and returns. It analyzes more than 400 specialty retailers across EMEA, LATAM and North America on 330 capabilities spanning four key experience areas: Shopping, Checkout, Fulfillment, and Service. The 2026 Benchmark reveals that while the industry has made steady progress in unified commerce maturity since 2023 when it was first launched, only 7% of retailers have achieved true unified commerce leadership while 33% are still stuck in the Basic category. Leaders are translating connected, data‑driven ye
Starr Completes Acquisition of IQUW Group23.3.2026 13:00:00 CET | Press release
Creates a stronger, more diversified global specialty platform Starr, a global investment and insurance organization, today announced that it has completed its acquisition of IQUW Group, creating a broader, more diversified specialty (re)insurance platform with enhanced capabilities across the London market, Bermuda and UK retail motor. The combined Starr business now serves more clients and brokers in more specialist classes and market segments globally. With IQUW Group, Starr has strengthened its position in the London market and established its managing agency as the ninth-largest at Lloyd’s. Importantly, Starr will continue to operate with a strong emphasis on underwriting expertise and best-in-class broker and client experience and service. Clients and brokers will benefit from a broader product offering, quick decision-making, greater capital strength and expanded global reach. Starr’s reinsurance capability is also significantly enhanced following this transaction. IQUW Re Bermu
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