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
OKX Launches X-Perps on the Magnificent 7 Stocks, Gold, Silver and Oil for European Traders9.6.2026 14:06:00 EEST | Press release
OKX, a leading global fintech company and crypto trading platform, today launched 13 new X-Perp markets for traders across Europe, giving retail users direct access to futures on the "Magnificent 7" tech stocks, four major commodities and the world's biggest* indices. From today, OKX customers in Europe can trade futures on Apple, Amazon, Alphabet, Meta, Microsoft, Nvidia and Tesla, alongside Gold, Silver, WTI Crude Oil and Brent Crude Oil. SPY and QQQ X-Perps are also available, allowing Europeans to build wealth by offering price exposure to the 500 largest US companies and the 100 largest non-financial Nasdaq companies respectively. On Friday June 12, following its IPO, X-Perps on SpaceX will also become available. All markets are available 24/7, with up to 10x leverage. Previously, acting on a Fed decision at midnight or a commodity spike over the weekend meant either waiting for markets to open or managing a separate brokerage account. X-Perps remove that constraint. Capital stays
Promega Receives SBTi Validation for Near-Term Science-Based Emissions Reduction Targets9.6.2026 14:01:00 EEST | Press release
Promega Corporation has received approval from the Science Based Targets initiative for its near-term emissions reduction targets, developed to reflect the current status of climate science. SBTi is a corporate climate organization that develops standards, tools and guidance for setting greenhouse gas emissions reductions targets in line with what is needed to avoid the worst impacts of climate change. “These goals aren’t just a commitment, they represent a verified plan with third-party accountability built in,” says Corey Meek, Corporate Responsibility Program Manager at Promega. “Our SBTi-validated targets reflect a comprehensive understanding of our greenhouse gas emissions across our entire value chain and set a clear, science-aligned standard for what we aim to achieve by 2030.” The Science Based Targets initiative has approved the following near-term targets: Scope 1 and 2: Reduce absolute Scope 1 and 2 emissions by 47% by 2030, from a 2023 baseline. Scope 3 (absolute reduction)
IFF’s 2025 Do More Good Report Highlights Progress in Nature-Based Innovation9.6.2026 14:00:00 EEST | Press release
IFF (NYSE: IFF) — a global leader in flavors, fragrances, food ingredients and health & biosciences — released its 2025 Do More Good Report, highlighting the company’s commitment to creating better products and experiences for people and the planet. IFF’s increasingly nature-based portfolio underscores the central role of sustainability and positions its innovation at the intersection of biology and chemistry. Through continued investment in R&D, expanded global innovation partnerships and measurable impact across the value chain, the report demonstrates how IFF is reducing environmental impact while delivering differentiated performance and long-term value for customers and consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608586967/en/ Cover image for IFF’s 2025 Do More Good report. “IFF’s 2025 Do More Good Report shows clear progress in advancing nature-based solutions and strengthening our portfolio,” said Eri
Icon Solutions Showcases How Banks Can Accelerate Digital Asset Innovation with IPF9.6.2026 12:30:00 EEST | Press release
Icon Solutions – the UK fintech enabling banks to design and implement state-of-the-art payment systems – has released a reference implementation showing how banks can use the Icon Payments Framework (IPF) to accelerate support for payments processing using distributed ledger technology (DLT)-based digital assets. As IPF is agnostic to both the type of digital asset and the DLT network on which they are issued, the risk of fragmentation is reduced as adoption scales. There is growing momentum for digital assets such as stablecoins, tokenised deposits, deposit tokens and central bank digital currencies (CBDCs) to enable faster, cheaper and smarter payments. Yet the emergence of different digital asset types and DLT networks – which must also work with existing financial infrastructure – creates fragmentation and operational complexity for banks. This is compounded by legacy vendor solutions that limit choice and lock banks in, making it slow, costly and risky to make the changes require
monday.com Appoints Ben Barnett General Manager of EMEA to Drive Next Phase of Regional Growth9.6.2026 11:00:00 EEST | Press release
monday.com (Nasdaq: MNDY), the AI work platform that turns strategy into execution at scale, today announced Ben Barnett’s appointment to General Manager (GM) of Europe, the Middle East and Africa, marking a major milestone in the company’s global expansion. Ben, who has been with monday.com for five years, brings a decade of experience in senior B2B sales roles at software companies and has overseen significant, sustained growth at monday.com in the UK and Ireland since joining in 2021. In his new position, Ben’s priorities include delivering the monday.com’s EMEA go-to-market strategy, fostering key partnerships, and bolstering its newly announced AI work platform. He is based in London. Ben’s promotion comes as monday.com builds on a period of rapid regional success, with EMEA revenue up 26% year-on-year in 2025. Last year, monday.com expanded its regional EMEA headquarters in Fitzrovia, London, now occupying 80,000 sq ft across three floors where more than 370 employees are based,
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