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Reveal Genomics' HER2DX Clinical Validation Trial Underway in Europe

NEW YORK – Reveal Genomics said Wednesday that its predictive and prognostic HER2 diagnostic, HER2DX, is undergoing evaluation in a clinical trial being conducted by the Hospital Clinic Foundation for Biomedical Research and the consortium August Pi i Sunyer Biomedical Research Institute, or FCRB-IDIBAPS.

The HER2DX assay is a 27-gene expression liquid biopsy test for patients with early-stage HER2-positive breast cancer. It combines clinical and genomic data and is designed to predict a breast cancer patient's risk of relapse and the likelihood of response to anti-HER2 treatment. Specifically, the quantitative test gauges the expression of ERBB2 mRNA across HER2-negative, HER2-low, and HER2-positive breast cancers.

The trial underway, called DEFINITIVE, will involve collaborators from 18 institutions across nine countries. The trial is funded by an €8 million ($8.7 million) grant from Horizon Europe, the European Commission's research funding program, and will be led by Tomás Pascual, a medical oncologist and researcher at FRCB-IDIBAPS.

If successful, the DEFINITIVE study will produce prospective validation data that Reveal hopes will spur guidelines bodies to recommend the HER2DX test, which in turn, can "ensure recognition and reimbursement across Europe," according to the firm.

The five-year randomized trial will assess the clinical efficacy of HER2DX by comparing outcomes between 300 patients at 44 sites in Europe and elsewhere with newly diagnosed stage II-IIIA HER2-positive breast cancer. Patients will be randomized to either treatment based on the HER2DX test results or treatment according to standard guidelines. Researchers will also evaluate the real-world applicability of the diagnostic by measuring quality of life, treatment toxicity, and direct and indirect costs associated with the test.

Reveal, based in Barcelona, initially launched HER2DX in Europe in 2022. The test is also available for research use in the US, and Reveal previously partnered with Dana-Farber Cancer Institute to retrospectively analyze data and patient outcomes from three breast cancer trials at the institution. The company is also developing DNADX, an assay for predicting drug response and survival outcomes in patients with metastatic breast cancer on endocrine therapy and CDK4/6 inhibitors.