Assay Validation
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
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