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Reveal Genomics HER2DX Assay to Be Prospectively Evaluated in ECOG-ACRIN Trial

NEW YORK – Reveal Genomics said Tuesday that its diagnostic tool HER2DX will be prospectively studied within the ongoing CompassHER2 pCR trial led by the ECOG-ACRIN Cancer Research Group.

The Phase II CompassHER2 pCR trial is evaluating whether neoadjuvant treatment with paclitaxel and Genentech's HER2-targeted drugs Herceptin (trastuzumab) and Perjeta (pertuzumab) could eliminate the need for adjuvant chemotherapy for patients with HER2-positive stage II-IIIa breast cancer who have a pathologic complete response after surgery. The trial, which is fully enrolled with more than 2,100 participants, is now in the follow-up phase.

Under the collaboration with Reveal, researchers amended the CompassHER2 pCR trial protocol to incorporate the HER2DX genomic test. Researchers will now generate a pathologic complete response score and recurrence risk score using HER2DX on pre-treatment samples and assess the ability of these scores to predict patient outcomes as a secondary endpoint in the trial.

HER2DX is a 27-gene expression test for early-stage HER2-positive breast cancer. The test combines clinical and genomic data to predict a patient's risk of cancer recurrence, assess the likelihood of pathologic complete response with an anti-HER2 therapy, and quantify ERBB2 expression. Reveal launched the HER2DX assay in Europe in 2022.

"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," Nadine Tung, director of the cancer genetics and prevention program at Beth Israel Deaconess Medical Center and principal investigator of the CompassHER2 pCR trial, said in a statement. "If proven and validated, this assay could fundamentally change our approach to treating HER2-positive breast cancer."

The Barcelona, Spain-based firm has conducted retrospective studies of HER2DX to gauge its ability to identify patients who are likely to respond to certain neoadjuvant treatments. In February, Reveal said the assay is also being evaluated in a separate trial being conducted by the Hospital Clinic Foundation for Biomedical Research and the consortium August Pi i Sunyer Biomedical Research Institute, or FCRB-IDIBAPS.