Reveal Genomics and IEO Collaborate on HER2DX® Test Decision-Making Study

Reveal Genomics, a Barcelona-based biotechnology startup focused on revolutionizing precision oncology through biomarker innovation, has partnered with the European Institute of Oncology (IEO) to launch a groundbreaking impact study on HER2DX®, the world’s first specialized genomic test for HER2+ breast cancer.

Reveal Genomics, a biotechnology startup based in Barcelona, has partnered with the European Institute of Oncology (IEO) to launch a groundbreaking study called “HER2-BREAST-DX.” The study, funded by the Umberto Veronesi Foundation, aims to evaluate the impact of the HER2DX® test on therapeutic decision-making for patients with early-stage HER2+ breast cancer. The goal of the research is to assess how the test influences treatment decisions for patients diagnosed with localized HER2+ breast cancer (stage I-IIIA), who are candidates for neoadjuvant (pre-surgery) or adjuvant (post-surgery) treatments.

The study’s primary objective is to enhance the personalization of treatments and further refine the decision-making process for clinicians. The collaboration brings together the expertise of Reveal Genomics, IEO, and the Umberto Veronesi Foundation, an organization known for supporting excellence in scientific research and health education. The Foundation is committed to funding this impactful study.

Dr. Patricia Villagrasa-González, CEO and co-founder of Reveal Genomics, emphasized that this new study will add to the existing research being conducted in Spain, validating the HER2DX® test for routine clinical use. She believes that collaborations with prestigious institutions like IEO will foster wider adoption of the test across Europe.

Dr. Carmen Criscitiello, a Medical Oncologist at IEO and principal investigator of the study, expressed excitement about using HER2DX® to refine treatment decisions for HER2+ breast cancer patients. She noted that this initiative reflects IEO’s ongoing commitment to personalized therapy and improving patient outcomes.

The study involves collecting oncology data through two intention-to-treat surveys: one before and one after requesting HER2DX® testing. In addition, clinical and pathological variables, as well as responses to neoadjuvant treatment, will be tracked. The study aims to examine how the HER2DX® test results might influence treatment recommendations, including adjusting the duration of adjuvant anti-HER2 treatment, modifying chemotherapy regimens, and determining the timing of surgery.

HER2DX® is the world’s first diagnostic test specifically designed for HER2+ breast cancer. Developed by Reveal Genomics and launched in January 2022, this 27-gene expression test integrates clinical data with genomic information to predict recurrence risk, treatment response, and expression of key biomarkers such as ERBB2. The test is designed to help physicians make more accurate, personalized decisions regarding HER2+ breast cancer treatment.

HER2+ breast cancer accounts for 20% of all breast cancer cases, with over 390,000 new diagnoses each year globally. Understanding the biological heterogeneity of HER2+ breast cancer is crucial for selecting the most effective systemic therapies.

This study not only aims to enhance the clinical utility of the HER2DX® test but also strives to integrate it into routine clinical practice, ultimately improving patient care and outcomes.

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