BC-Monitor: Towards a Routinely Accessible Circulating Tumor DNA-Based Tool for Real-Time Monitoring Breast Cancer Progression and Treatment Effectiveness

We are pleased to announce that our BC-monitor, a breast cancer-specific ctDNA diagnostic tool, is now published. This innovative tool effectively detects preclinical metastases and relapses earlier than conventional methods. It identifies evolving mutations in real-time, revealing new pathogenic variants in follow-up plasma samples not found in primary tumors or baseline samples. By monitoring disease progression, this approach enhances treatment strategies, potentially improving therapy effectiveness significantly.

The BC-monitor is a newly developed, breast cancer-specific circulating tumor DNA (ctDNA) diagnostic tool designed for real-time monitoring of disease progression and treatment effectiveness. Using an optimized multiplex PCR-based next-generation sequencing protocol, the BC-monitor can detect allele variant frequencies below 1% in cell-free plasma DNA, providing high sensitivity for identifying mutations associated with breast cancer. In a prospective study of 45 breast cancer patients receiving neoadjuvant chemotherapy, endocrine therapy, or palliative therapy for metastatic disease, the tool was able to identify traceable mutations in approximately two-thirds of cases. Notably, the BC-monitor detected new pathogenic variants in follow-up plasma samples that were not present in the primary tumor or baseline plasma, highlighting its ability to capture tumor evolution in real time.

The BC-monitor predicted disease progression four to six months earlier than conventional clinical and imaging methods, offering a significant lead time for therapeutic decision-making. Its gene panel was carefully designed based on the most frequent and clinically actionable genetic alterations in breast cancer. The test requires minimal sample input and is cost-effective, making it suitable for routine clinical use. By integrating ctDNA monitoring into regular patient care, clinicians can receive early warnings of relapse or metastasis and adjust treatments accordingly, potentially improving patient outcomes.

The study emphasizes the importance of continuous ctDNA monitoring during and after therapy, as it provides dynamic information on the presence of active tumor DNA in the bloodstream. The BC-monitor approach addresses the limitations of many existing ctDNA assays by balancing sensitivity, coverage, turnaround time, and sample requirements. Overall, the BC-monitor represents a practical and accessible tool for enhancing breast cancer management, enabling earlier intervention and more personalized treatment strategies. Its successful clinical validation suggests it could become a standard component of breast cancer follow-up and therapy assessment in the near future.

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