REVEAL GENOMICS Unveils Breakthrough CNS Progression Score for HER2+ Breast Cancer Brain Metastasis Prediction at SABCS 2025
核心洞察
REVEAL GENOMICS (搜索) presented seven studies at SABCS 2025 analyzing over 1,300 tumor samples, showcasing major advances in precision oncology for breast cancer patients.
The company's newly developed HER2DX (搜索) CNS Progression (搜索) Score demonstrated strong risk stratification ability, with 3-year CNS progression rates of 39.2% in high-risk versus 4.3% in low-risk groups.
Multiple validation studies confirmed the superior predictive performance of HER2DX (搜索) genomic scores over traditional biomarkers like tumor-infiltrating lymphocytes across different breast cancer subtypes.
REVEAL GENOMICS (搜索), a Barcelona-based biotechnology company, announced groundbreaking advances in predicting brain metastasis (搜索) risk for HER2-positive breast cancer (搜索) patients at the San Antonio Breast Cancer Symposium (SABCS) 2025. The company presented seven studies analyzing more than 1,300 tumor samples from individuals with HER2 (搜索)-positive, ER-negative, and triple-negative breast cancer (搜索), representing one of the most extensive genomic contributions to the conference.
Revolutionary CNS Progression Score Addresses Critical Unmet Need
The most significant breakthrough involves REVEAL GENOMICS (搜索)' newly developed HER2DX (搜索) CNS Progression (搜索) Score, which addresses a major clinical challenge in advanced HER2-positive breast cancer (搜索) care. CNS progression remains a major unmet need, and until now no biomarker has been available to identify those at highest risk.
In a validation cohort of 215 individuals with advanced HER2-positive breast cancer (搜索) from Spain and Poland, the HER2DX (搜索) CNS Progression (搜索) Score demonstrated remarkable risk stratification capabilities. The 3-year cumulative incidence of CNS progression was 39.2% in the high-risk group, 13% in the intermediate-risk group, and 4.3% in the low-risk group.
The studies showed that the HER2DX (搜索) ERBB2 (搜索) score, together with two newly developed genomic scores, independently predicts overall survival and the risk of brain progression in individuals treated with first-line therapy and in subsequent treatment settings. These findings are particularly relevant in a landscape where multiple therapeutic options now exist, each with different levels of efficacy and tolerability.
Clinical Trial Integration Demonstrates Operational Feasibility
The ongoing DEFINITIVE trial (NCT06446882), an international, multicenter, randomized prospective clinical trial across Europe and Israel funded by the European Union, provided compelling evidence for the operational feasibility of genomic testing in real-world clinical settings. The trial evaluates the impact of HER2DX (搜索)-guided treatment in stage II-III HER2-positive breast cancer (搜索).
Real-time operational insights from the first 122 patients screened showed that HER2DX (搜索) testing was successfully completed in 115 cases, achieving a 94.3% success rate. The median turnaround time from sample reception to result was 7 working days, confirming the feasibility of rapid, centralized genomic testing and supporting the integration of genomic classifiers into real-time treatment decision-making in prospective clinical trials.
Superior Predictive Performance Over Traditional Biomarkers
REVEAL GENOMICS (搜索) presented compelling evidence that their HER2DX (搜索) scores outperform traditional biomarkers. In the COMPASSHER2 pCR trial from ECOG-ACRIN (搜索), researchers compared tumor-infiltrating lymphocytes (TILs) performance with the HER2DX pCR score in 569 patients. The HER2DX pCR score emerged as the only variable independently associated with pathologic complete response (pCR), even after adjusting for TILs.
Notably, TILs were no longer predictive once the HER2DX (搜索) pCR score was included in the analysis, reinforcing the superior predictive ability of the HER2DX pCR score compared with TILs alone for identifying patients most likely to achieve a pCR. These findings were recently published in Clinical Cancer Research.
RNA-Based HER2 Assessment Shows Perfect Concordance
A prospective pilot study evaluated whether the ERBB2 (搜索) mRNA score could streamline HER2 (搜索) assessment in ER-negative breast cancer (搜索). The ERBB2 mRNA score demonstrated perfect concordance with standard HER2 classification, correctly identifying every HER2-positive and HER2-negative case. These findings support RNA-based HER2 assessment as an accurate, rapid, and operationally simple approach that can help accelerate neoadjuvant decision-making in ER-negative disease.
Triple-Negative Breast Cancer Platform Receives Independent Validation
An independent validation study in 164 patients from two Spanish academic centers confirmed that the TNBCDX (搜索) 15-gene assay accurately predicts pCR and recurrence risk in early-stage triple-negative breast cancer (搜索) (TNBC), irrespective of anthracycline (搜索) or pembrolizumab use. Combined with the original 527-patient dataset from the Annals of Oncology publication, this provides converging evidence that TNBCDX is a robust and reproducible tool for refining risk stratification and supporting more individualized systemic therapy decisions in early-stage TNBC.
Leadership Vision for Precision Oncology
Prof. Aleix Prat, MD, PhD, Co-founder and CSO of REVEAL GENOMICS (搜索), emphasized the clinical impact of these findings: "These results reflect years of collaborative research and our commitment to translating genomic science into real-world benefits for patients. We are proud to see our tools making a tangible difference in breast cancer care. The breadth of data presented at SABCS 2025 demonstrates the versatility and clinical impact of our genomic platforms."
Dr Patricia Villagrasa, Co-founder and CEO, added: "Our mission is to empower clinicians and patients with the best possible information for treatment decisions. The progress showcased at SABCS 2025 is a clear reflection of our team's dedication and the trust placed in us by the oncology community."
REVEAL GENOMICS (搜索) is a spin-off company of Hospital Clínic of Barcelona (搜索), IDIBAPS, the University of Barcelona, and the Vall d'Hebron Institute of Oncology (搜索), dedicated to developing innovative genomic solutions that empower clinicians and patients with actionable insights for precision cancer care.