Reveal Genomics® to Evaluate Prospective Real-time Performance of HER2DX® Genomic Test in the United States
18 June 2024 - 1:05PM
Business Wire
- 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.
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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 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.
About REVEAL GENOMICS®
REVEAL GENOMICS, S.L. is a biotechnology start-up seeking to
change the way biomarkers are used in oncology. It is focused on
developing innovative diagnostic tools to define the best
therapeutic options for patients with cancer. The company uses
pioneering techniques, sophisticated computer applications, and
machine learning to reveal new cancer research data.
REVEAL GENOMICS, S.L. is a spin-off company of Hospital Clínic
of Barcelona, IDIBAPS, the University of Barcelona (U.B.), and the
Vall d’Hebron Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL
GENOMICS, S.L.
Web: www.reveal-genomics.com. Twitter:
@revealgenomics
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version on businesswire.com: https://www.businesswire.com/news/home/20240618298933/en/
Further information: Adriana Herrera,
aherrera@reveal-genomics.com