Groundbreaking Study Confirms Clinical Decision Impact of HER2DX® Genomic Assay in Early-Stage HER2-Positive Breast Cancer

This is the first prospective real-world investigation assessing the impact of HER2DX® results on treatment decision-making in clinical practice. HER2DX® impacted treatment decisions in ~50% of cases, leading to more personalized therapy approaches.Most treatment modifications resulted in reduced chemotherapy or anti-HER2 therapy intensity without compromising outcomes.The study highlights potential costs savings with the use of HER2DX®.

REVEAL GENOMICS^®, a pioneering Barcelona-based biotech company dedicated to advancing precision oncology, is proud to announce 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.

The study, now published in ESMO 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.

About REVEAL GENOMICS^®

REVEAL GENOMICS, S.L. is a biotechnology start-up dedicated to redefining the role of biomarkers in oncology. The company focuses on developing innovative diagnostic tools that optimize therapeutic decision-making for patients with cancer. By leveraging advanced genomic technologies, sophisticated computational algorithms, and machine learning, REVEAL GENOMICS^® generates novel insights into cancer biology and treatment response.

The company has developed HER2DX^®, TNBCDX^®, and DNADX^®, state-of-the-art genomic assays that provide prognostic and predictive information to guide personalized cancer treatment strategies. REVEAL GENOMICS, S.L. is a spin-off of Hospital Clínic of Barcelona, IDIBAPS, the University of Barcelona (U.B.), and the Vall d’Hebron Institute of Oncology (VHIO), bringing together expertise from leading academic and clinical institutions to advance precision oncology.

For further information visit: http://www.reveal-genomics.com

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