Reveal Genomics and the Istituto Europeo di Oncologia (IEO) have initiated an impact study of the genomic test, HER2DX, to determine its application in treatment decisions for patients with early-stage human epidermal growth factor receptor 2+(HER2+) breast cancer.

The collaborative ‘HER2DX TEST DECISION IMPACT STUDY’ project, which will receive funding from the Umberto Veronesi Foundation, aims to personalise treatment for HER2+ breast cancer patients.

The IEO is committed to incorporating the HER2DX test into clinical practice and assessing its impact on specialist decision-making.

Oncologists participating in the study will complete surveys before and after receiving HER2DX outcomes, providing insight into the test's usefulness and its integration into routine healthcare.

IEO medical oncologist Dr Carmen Criscitiello said: "As the principal investigator of this pivotal study, I am excited to collaborate with REVEAL GENOMICS and leverage the HER2DXtest to refine treatment decisions for HER2+ breast cancer patients.

“This project embodies our commitment at IEO to personalise therapy, aiming to enhance outcomes and optimise patient care."

Introduced to the market by Reveal Genomics in January 2022, HER2DX is a standardised 27-gene expression test designed specifically for early-stage HER2+ breast cancer.

It combines clinical data with genomic information to predict the risk of relapse, the likelihood of response to anti-HER2 treatment before surgery, and the quantitative expression of ERBB2 mRNA.

Reveal Genomics CEO and co-founder Dr Patricia Villagrasa-González said: "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."

The study's findings are set to help determine the clinical benefits and potential changes in treatment recommendations based on the results of the test.

The test is a prognostic and predictive tool that combines clinical information such as tumour size and nodal status with biological information.

The outcomes can influence various aspects of treatment, including the duration and type of chemotherapy and anti-HER2 treatment, as well as the timing of surgery.