Assay Validation for Clinical Sample Testing

Expert determination and optimization of assay performance
  • Validation from RUO to LDT (US) or CE-IVD (Europe) level according to GMP
  • Large scale sensitivity testing of cancer patient populations to understand expression patterns
  • Reproducibility & precision testing
  • Specificity analysis in cell lines, xenografts, animal tissues, & normal human tissues
  • Scoring scheme development driven by experienced pathologists
  • Expression rate analysis for cut-off determination
Precision & Reproducibility See an Example

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