DX PLATFORMS VALIDATION
Companion diagnostics play a critical role in precision oncology, enabling the identification of patients most likely to benefit from targeted therapies, as well as monitoring treatment response and detecting resistance mechanisms.
To ensure clinical decisions are accurate and reliable, diagnostic assays must meet the highest standards of analytical performance, reproducibility and clinical relevance.
Validation Expertise
Companion diagnostics play a critical role in precision oncology, enabling the identification of patients most likely to benefit from targeted therapies, as well as monitoring treatment response and detecting resistance mechanisms.
To ensure clinical decisions are accurate and reliable, diagnostic assays must meet the highest standards of analytical performance, reproducibility and clinical relevance.
We provide:
- Analytical and clinical validation of molecular assays
- Performance evaluation (sensitivity, specificity, reproducibility)
- Standardization of workflows under clinical-grade conditions
- Generation of high-quality data to support regulatory and clinical requirements
INTEGRATED APPROACH
Our validation capabilities are uniquely strengthened by the integration of:
- Advanced molecular diagnostics (NGS, nCounter, IHC, FISH)
- Access to real patient samples
- Translational research and preclinical models
This allows us to generate validation data that is not only technically robust, but also clinically meaningful.