ESR1 mutations have emerged as a key mechanism of acquired resistance to endocrine therapy in HR-positive/HER2-negative metastatic breast cancer and are increasingly recognized as clinically actionable biomarkers. As a result, liquid biopsy is becoming an essential tool for guiding treatment decisions and monitoring disease evolution through circulating tumor DNA (ctDNA).
Among available technologies, digital PCR (dPCR) offers exceptional sensitivity for the detection of low-frequency ESR1 mutations in research settings, together with rapid turnaround times and robust analytical performance, making it particularly well suited for research and development of potential clinical applications.
This webinar will review the clinical relevance of ESR1 testing, the role of dPCR in high-sensitivity ctDNA analysis, and the key requirements for assay validation and quality assurance in research settings. Experts will discuss findings from a recent European multicenter analytical verification study demonstrating the reproducibility and reliability of dPCR-based ESR1 testing across laboratories, as well as our real-world experience in clinical research presented at ESMO Breast 2025 on the implementation of liquid biopsy for ESR1 mutation detection in metastatic breast cancer research samples.
The session will provide practical insights for pathologists, molecular biologists, and laboratory professionals interested in applying digital PCR technologies for ESR1 research and assay workflow optimization.
Learning objectives:
Understand the clinical relevance of ESR1 mutations as a mechanism of acquired endocrine therapy resistance in HR-positive/HER2-negative metastatic breast cancer, and where liquid biopsy fits in monitoring disease evolution in research settings.
Learn how digital PCR delivers the analytical sensitivity, turnaround time, and reproducibility needed to detect low-frequency ESR1 mutations in ctDNA.
Review the key requirements for assay validation and quality assurance when implementing high-sensitivity ctDNA analysis in a research laboratory.
Gain insights from a European multicenter analytical verification study demonstrating cross-laboratory reproducibility of dPCR-based ESR1 testing.
See how these workflows perform in practice through real-world clinical research experience presented at ESMO Breast 2025.
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