• The study aims to determine the impact of applying HER2DX^® in medical decisions regarding treatment for patients diagnosed with localized HER2+ breast cancer (stage I-IIIA).

• The project is the result of the combined efforts of REVEAL GENOMICS^® and the IEO, along with the Umberto Veronesi Foundation.

REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, and the Istituto Europeo di Oncologia (IEO) today announced the start of an impact study of the HER2DX^® test, the first genomic test in the world specialized in HER2+ breast cancer.

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The project, entitled "Prospective observational monocentric study to evaluate the impact of the HER2DX^® assay on treatment decisions in patients with early-stage HER2+ breast cancer: HER2-BREAST-DX," aims to determine the impact of applying the test in medical decisions regarding treatment for patients diagnosed with localized HER2+ breast cancer (stage I-IIIA). These patients are candidates for either neoadjuvant treatment (prior to surgery) or adjuvant treatment (post-surgery). The project therefore seeks to advance the personalization of treatments.

The project is the result of the combined efforts of both REVEAL GENOMICS^® and the IEO, along with the Umberto Veronesi Foundation, which promotes excellence in scientific research as well as initiatives for prevention, health education, and science outreach.

Umberto Veronesi Foundation is committed to funding the HER2DX® TEST DECISION IMPACT STUDY project.

This collaboration reflects the IEO's commitment to integrating the test into clinical practice while evaluating its impact on specialists’ decision-making.

Dr. Patricia Villagrasa-González, CEO and co-founder of REVEAL GENOMICS^®, says about the agreement, "This new Decision Impact Study joins the ones we are already conducting in Spain, allowing us to demonstrate the robustness of HER2DX^® for use in daily clinical practice. Agreements like this one with prestigious entities such as IEO clearly benefit us all and promote the adoption of the test in the European context."

Dr. Carmen Criscitiello, medical oncologist at IEO, adds, "As the principal investigator of this pivotal study, I am excited to collaborate with REVEAL GENOMICS^® and leverage the HER2DX^® test to refine treatment decisions for HER2+ breast cancer patients. This project embodies our commitment at IEO to personalize therapy, aiming to enhance outcomes and optimize patient care."

THE IEO DECISION IMPACT STUDY: HER2DX^® IN CLINICAL PRACTICE

The study involves collecting data from oncologists, who complete two surveys on treatment intent: one before requesting HER2DX^®, and the other after receiving the results. The study also includes clinical and pathological variables, as well as response to neoadjuvant treatment.

The results will provide further data on the usefulness of the test and the clinical benefit it brings to patients, as well as assessing how it can be adapted naturally in routine clinical practice within the healthcare system. The aim is also to look at how the test results may influence treatment recommendations.

Changes in treatment recommendations could include adjustments to the duration of adjuvant anti-HER2 treatment; changes in the type of chemotherapy recommended before and after the test; changes in the type of anti-HER2 treatment; and changes in the timing of surgery (before or after systemic treatment).

About HER2DX^®️

HER2DX^®️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS^®️ since January 2022, the HER2DX^® is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX^®️ is a prognostic and 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 HER2+ breast cancer

HER2+ breast cancer accounts for 20% of all diagnosed breast tumors. This represents more than 390,000 new cases diagnosed worldwide every year, meaning that, on average, 3 women are diagnosed with HER2+ breast cancer every 4 minutes. HER2+ breast cancer is clinically and biologically heterogeneous, and standard clinical-pathological assessment has proven insufficient in capturing this heterogeneity. Understanding this biological heterogeneity is key to identifying the prognosis of each patient and the benefit from systemic therapies that target HER2.

About IEO

The IEO (European Institute of Oncology) is one of the world's most prestigious hospitals and the fastest growing comprehensive cancer center in Europe. IEO integrates various areas related to the fight against cancer, such as prevention, diagnosis, treatment, training and education, and basic and translational research. The European Institute of Oncology (Istituto Europeo di Oncologia - IEO) strives for excellence in cancer prevention, early diagnosis, and effective treatment. It aims to achieve this through clinical and scientific research development and organizational and management innovation, with a constant focus on the quality of the service provided to patients.

About Umberto Veronesi Foundation

Umberto Veronesi Foundation was established in 2003 by Umberto Veronesi, a pioneering oncologist in cancer treatments and in the international scientific community.

The Foundation puts all its energy into finding new treatments for cancer and supporting outstanding scientific research, while raising awareness about cancer prevention among young people and adults.

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, the University of Barcelona (U.B.), and the 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

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