High-Sensitivity ESR1 Detection by Digital PCR in Metastatic Breast Cancer Research Samples: From Analytical Validation to Potential Clinical Applications

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.

November 3, 2026

The Pathologist

Objective:

To review the clinical relevance of ESR1 mutations and the role of digital PCR in high-sensitivity ctDNA analysis for metastatic breast cancer.

Approach:

Digital PCR Technology: Examine how digital PCR provides the necessary sensitivity, turnaround time, and reproducibility for detecting low-frequency ESR1 mutations in ctDNA.
Assay Validation and Quality Assurance: Review key requirements for implementing high-sensitivity ctDNA analysis in research laboratories.
Multicenter Analytical Verification Study: Present findings from a European study demonstrating the reproducibility and reliability of dPCR-based ESR1 testing across laboratories.
Real-World Clinical Research Experience: Share insights from clinical research presented at ESMO Breast 2025 regarding the implementation of liquid biopsy for ESR1 mutation detection.

Key Findings:

ESR1 mutations are clinically actionable biomarkers in metastatic breast cancer.
Digital PCR offers exceptional sensitivity for detecting low-frequency ESR1 mutations.
A European multicenter study confirmed the reproducibility of dPCR-based ESR1 testing across different laboratories.

Interpretation:

The findings highlight the potential of digital PCR in enhancing the detection and monitoring of ESR1 mutations in metastatic breast cancer research.

Limitations:

Content is intended for research use only and not for diagnostic procedures.
The views expressed do not reflect the official policy or endorsements of Bio-Rad Laboratories.