Study Confirms HER2DX® Assay’s Impact on Early-Stage HER2-Positive Breast Cancer Decisions
REVEAL GENOMICS®, an innovative biotech company based in Barcelona, is excited to announce the publication of a groundbreaking study showcasing the clinical impact of HER2DX®, its genomic diagnostic test for early-stage HER2-positive (HER2+) breast cancer.
REVEAL GENOMICS®, a pioneering biotech company based in Barcelona, is proud to announce the publication of a groundbreaking study that demonstrates the clinical impact of its genomic diagnostic test, HER2DX®. The study, published in ESMO Real World Data and Digital Oncology, marks the first prospective real-world investigation into how HER2DX® influences treatment decisions in clinical practice for early-stage HER2-positive (HER2+) breast cancer.
Led by Dr. Olga Martínez-Sáez, Dr. Juan Miguel Cejalvo, and Dr. Antonio Llombart-Cussac, the study analyzed how HER2DX® results affected treatment plans for 297 patients with stage I-III HER2+ breast cancer across multiple hospitals in Spain. The findings are highly significant, revealing that HER2DX® led to modifications in the treatment approach for 48.1% of patients. Notably, 75.5% of these changes resulted in a reduction of treatment intensity, particularly through decreased chemotherapy and/or anti-HER2 therapies, without compromising patient outcomes. This demonstrates the potential of HER2DX® to help tailor treatments in a way that reduces unnecessary side effects while maintaining effectiveness.
The study further highlighted the predictive strength of HER2DX® in identifying patients who are more likely to achieve a pathologic complete response (pCR) after treatment. This reinforces the test’s utility as a crucial tool in selecting the most appropriate therapies based on individual patient profiles.
In addition to clinical benefits, the study found that oncologists experienced a significant increase in confidence when making treatment decisions guided by HER2DX® data. Healthcare professionals reported a clearer understanding of each patient’s potential response to treatment, which allowed them to make more informed and precise decisions. The study also emphasized the economic advantages of integrating HER2DX® into clinical practice, with potential cost savings realized through more efficient use of resources and reduction of unnecessary drug prescriptions and treatments.
Dr. Olga Martínez Sáez, a breast medical oncologist at Clinic Barcelona Comprehensive Cancer Center and Principal Investigator of the study, commented: “This study represents a significant step forward in personalized oncology. HER2DX® empowers physicians to make more precise, evidence-based decisions with greater confidence, ultimately improving patient care and outcomes.”
Dr. Juan Miguel Cejalvo, a breast medical oncologist at Hospital Clínico Universitario de Valencia/INCLIVA and co-Principal Investigator of the study, emphasized the importance of integrating genomic tools into everyday clinical practice. “These results confirm that HER2DX® provides valuable insights that can refine treatment strategies. It allows for more personalized care, while still ensuring excellent clinical outcomes for patients,” he said.
Dr. Antonio Llombart-Cussac, Head of the Medical Oncology Department at Hospital Arnau de Vilanova in Valencia, also noted the significance of the findings: “The ability to predict a patient’s response to therapy before treatment begins allows oncologists to adjust the treatment intensity appropriately. This reduces unnecessary toxicity and healthcare costs, making the approach both clinically effective and cost-efficient.”
Patricia Villagrasa, CEO of REVEAL GENOMICS®, emphasized the company’s mission and the significance of this study in advancing cancer care: “Our goal is to revolutionize cancer care with cutting-edge genomic insights. HER2DX® is a key tool in personalized medicine, enabling oncologists to make more informed decisions for their patients. This first clinical utility study confirms its potential to significantly improve HER2+ breast cancer treatment.”
About HER2DX®
HER2DX® is a state-of-the-art genomic diagnostic test designed specifically for early-stage HER2+ breast cancer. Launched by REVEAL GENOMICS® in January 2022, HER2DX® is a standardized 27-gene expression test that integrates clinical data, such as tumor size and nodal status, with molecular information on immune response, luminal differentiation, tumor proliferation, and the expression of the HER2 17q12-21 chromosomal amplicon. HER2DX® predicts:
- Risk of relapse score: Identifies the risk of recurrence in newly diagnosed HER2+ breast cancer patients.
- pCR likelihood score: Predicts the likelihood of a patient responding to anti-HER2-based treatment before surgery.
- ERBB2 score: Quantifies ERBB2 mRNA expression across HER2-negative, HER2-low, and HER2+ breast cancer.
About HER2+ Breast Cancer
HER2+ breast cancer accounts for approximately 20% of all breast cancer cases, with over 390,000 new diagnoses worldwide each year. Despite advancements, HER2+ breast cancer remains biologically and clinically heterogeneous. Standard clinical assessments are often inadequate in capturing this complexity. Understanding the biological differences among HER2+ breast cancers is crucial for predicting prognosis and guiding therapy.
About REVEAL GENOMICS®
REVEAL GENOMICS® is a biotechnology company focused on developing innovative diagnostic tools for oncology. The company’s mission is to optimize treatment decisions for cancer patients through advanced genomic insights, machine learning, and computational algorithms. REVEAL GENOMICS® offers a suite of diagnostic assays, including HER2DX®, TNBCDX®, and DNADX®, all designed to provide predictive and prognostic data to guide personalized treatment strategies. As a spin-off from Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona, and the Vall d’Hebron Institute of Oncology, REVEAL GENOMICS® combines the expertise of leading academic and clinical institutions to drive precision oncology forward.
