On March 10, 2025 REVEAL GENOMICS, a pioneering Barcelona-based biotech company dedicated to advancing precision oncology, reported the publication of a groundbreaking study demonstrating the clinical impact of HER2DX, its genomic diagnostic test designed for early-stage HER2-positive (HER2+) breast cancer (Press release, REVEAL GENOMICS, MAR 10, 2025, View Source [SID1234651052]).
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The study, now published in ESMO (Free ESMO Whitepaper) Real World Data and Digital Oncology, is the first prospective real-world investigation assessing the impact of HER2DX results on treatment decision-making in clinical practice.
The study, led by Dr. Olga Martínez-Sáez, Dr. Juan Miguel Cejalvo, and Dr. Antonio Llombart-Cussac, evaluated how HER2DX impacted treatment decisions in a cohort of 297 patients with stage I-III HER2+ breast cancer across multiple hospitals in Spain. The primary findings reveal that HER2DX led to a modification in the treatment plan in 48.1% of cases, with most changes (75.5%) leading to a reduction in treatment intensity, reducing chemotherapy and/or anti-HER2 without compromising outcomes.
HER2DX also demonstrated strong predictive capability, accurately identifying patients with a higher likelihood of achieving a pathologic complete response (pCR), reinforcing its role as a crucial tool in therapy selection.
Additionally, oncologists reported a significant increase in confidence when making treatment decisions based on HER2DX data. Finally, the study also underscored the economic benefits of incorporating HER2DX into clinical practice, with healthcare cost savings when drug costs and type of vein access were taken into account, further validating its role in optimizing treatment strategies and reducing unnecessary interventions.
Dr. Olga Martínez Sáez, breast medical oncologist at Clinic Barcelona Comprehensive Cancer Center and Principal Investigator (PI) of the study, added: "This study represents a significant step forward in personalized oncology. HER2DX enables physicians to make precision-guided decisions with greater confidence, improving patient care."
Dr. Juan Miguel Cejalvo, breast medical oncologist at Hospital Clínico Universitario de Valencia/INCLIVA, and co-PI of the study, emphasized the importance of integrating genomic tools into routine clinical practice, "These results confirm that HER2DX provides valuable information that can refine treatment strategies, allowing for more personalized care while maintaining excellent outcomes."
Dr. Antonio Llombart-Cussac, head of the medical oncology department at Hospital Arnau de Vilanova in Valencia, and investigator of the study, highlighted the impact on clinical practice, "The capacity to forecast a patient’s therapeutic response prior to treatment initiation allows oncologists to adjust treatment intensity appropriately, effectively reducing unnecessary toxicity and healthcare costs."
Patricia Villagrasa, CEO of REVEAL GENOMICS, underscored the company’s mission, "Our goal is to revolutionize cancer care with cutting-edge genomic insights, helping oncologists make more informed decisions and benefiting patients. The results of this first clinical utility study confirms HER2DX as a key tool in precision medicine for HER2+ breast cancer."
About HER2DX
HER2DX is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS since January 2022, 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.