REVEAL GENOMICS® to evaluate prospective real-time performance of HER2DX® genomic test in the United States

June 18, 2024

- The study in collaboration with Dana-Farber Cancer Institute will evaluate how HER2DX® enhances the confidence of both patients and physicians in making informed therapeutic decisions, highlighting its potential to revolutionize precision oncology and improve patient outcomes.

- For the first time in the United States, a collaborative study aims to demonstrate the feasibility and impact of real-time HER2DX® testing in patients with early-stage HER2+ breast cancer.

REVEAL GENOMICS, S.L., a pioneering biotechnology start-up based in Barcelona set to revolutionize precision oncology through biomarker innovation, has announced the start of a prospective study in collaboration with the Dana-Farber Cancer Institute (Dana-Farber). This trial will evaluate the turnaround time of the HER2DX® genomic test to determine its feasibility in clinical practice in the US.

HER2DX® test results are currently generated and managed in Barcelona, Spain, with an average turnaround time of 8.1 business days, according to data presented at the ESMO Breast Conference last May. This study at Dana-Farber aims to additionally evaluate the turnaround time of HER2DX® conducted at Brigham and Women's Center for Advanced Molecular Diagnostics (CAMD, Boston, MA, USA) in tumor samples of patients with newly diagnosed HER2+ early-stage breast cancer

The study will also examine how the HER2DX® test results influence therapeutic decisions by DFCI physicians for patients with stage I-III HER2+ breast cancer, and the confidence levels of both patients and physicians before and after the test.

Patricia Villagrasa, REVEAL GENOMICS' CEO, says, “We are excited to see the HER2DX® test being used in the United States to improve clinical decision-making and patient outcomes. This collaboration with DFCI is a significant milestone in our mission to enhance precision oncology through innovative biomarker solutions.

Sara M. Tolaney, MD, MPH, Chief of Division of Breast Oncology and Associate Director of the Susan F. Smith Center for Women's Cancers at DFCI, adds, “The HER2DX® test has the potential to significantly influence therapeutic decisions for patients with HER2+ breast cancer. We are excited to be the first center in the United States to incorporate HER2DX® and to explore its practical application in diverse clinical environments.”

Adrienne G. Waks, MD, and Principal Investigator of the study at the DFCI, notes: “In addition to its potential incorporation into clinical practice, the fact that the study analyzes decision-making and collects information on physician and patient opinions makes the results of this study very powerful data for the routine use of the test.”

The study will include patients with newly diagnosed stage 1-3 HER2+ breast cancer. In addition to assessing turnaround time, the study will provide questionnaires to patients to assess their basic understanding of their disease and the HER2DX®️ assay, and to physicians to assess their pre-assay treatment choice and confidence in the results. The study team will record the physician researcher’s choice of treatment before and after the HER2DX®️ results.