On June 18, 2024 REVEAL GENOMICS, S.L., a pioneering biotechnology start-up based in Barcelona set to revolutionize precision oncology through biomarker innovation, reported the start of a prospective study in collaboration with the Dana-Farber Cancer Institute (Dana-Farber) (Press release, REVEAL GENOMICS, JUN 18, 2024, View Source [SID1234644433]). This trial will evaluate the turnaround time of the HER2DX genomic test to determine its feasibility in clinical practice in the US.

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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 (Free ESMO Whitepaper) 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 Dana-Farber 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 the Dana-Farber Cancer Institute 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 Dana-Farber, 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 Dana-Farber, 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 I-III 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.

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.