Reveal Genomics announced that its genomic assay, dubbed HER2DX, shows significant impact on clinical decision-making for early-stage HER2-positive breast cancer.
The Spanish biotech company’s announcement is based on a recently published study.
The study confirmed the genomic assay’s role in optimising treatment strategies and reducing unnecessary interventions for patients.
Launched in January 2022, HER2DX is the first diagnostic test specifically formulated for human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
It is a 27-gene expression test that combines clinical data, such as tumour size and nodal status, with genomic insights, including immune response and ERBB2 gene expression.
Also, the genomic assay is designed to predict relapse risk, likelihood of response to anti-HER2 treatment, and ERBB2 mRNA expression levels.
Reveal Genomics CEO Patricia Villagrasa said: “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.”
The study, led by Dr Olga Martínez-Sáez, Dr Juan Miguel Cejalvo, and Dr Antonio Llombart-Cussac, is the first prospective real-world investigation of HER2DX.
It evaluated 297 patients with stage 1 to 3 HER2-positive breast cancer across multiple hospitals in Spain.
The study results show that HER2DX influenced treatment modifications in 48.1% of cases, with 75.5% of changes helped reduce treatment intensity without compromising outcomes.
HER2DX showed strong predictive capabilities, accurately identifying patients with a higher likelihood of achieving a pathologic complete response.
The study highlighted the economic benefits of integrating HER2DX into clinical practice.
It showed that the assay contributes to healthcare cost savings, considering drug costs and vein access types, and further validated its role in optimising treatment strategies.
The study principal investigator (PI) Olga Martínez Sáez said: “This study represents a significant step forward in personalized oncology. HER2DX enables physicians to make precision-guided decisions with greater confidence, improving patient care.”
co-PI of the study Juan Miguel Cejalvo said: “These results confirm that HER2DX provides valuable information that can refine treatment strategies, allowing for more personalized care while maintaining excellent outcomes.”
The study investigator Antonio Llombart-Cussac said: “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.”
