Biomarkers and Companion diagnostics in CGT Trials: Enabling precision and predictability
12 Feb 2026
Theatre 3
Clinical and translational excellence
Biomarkers and companion diagnostics are central to optimizing CGT study design, dose selection, and patient stratification. This spotlight session reviews frameworks for defining analytical performance, aligning diagnostic strategy with clinical endpoints, and improving predictive validity for human subjects.
Key takeaways
- Select biomarkers that align with mechanism of action and clinical endpoints
- Define validation requirements for companion diagnostics in CGT studies
- Integrate biomarker data to guide dose selection and safety margin assessment
- Apply diagnostic strategies that support patient stratification and trial efficiency
- Strengthen predictive validity by linking nonclinical and early human readouts
