Superior Assay Validation - Beyond Optimization
Our experts have designed an industry-leading assay validation approach that starts with careful assay development and optimization, but doesn’t stop there. We do more than simply demonstrate that an assay can detect a target in various conditions, we:
- Conduct large scale sensitivity screening of cancer patient populations to understand expression patterns within and among tumor indications
- Demonstrate precision and reproducibility using serial sections from samples with various levels of known target expression (from sensitivity screen)
- Analyze specificity in cell lines, xenografts, and normal human tissues
- Develop a robust scoring scheme to properly and consistently capture level of target expression
- Analyze expression rate for cut-off determination in various disease indications
A High Expression Level Example
Precision and reproducibility testing is formatted such that samples from each expression level (high, moderate, low and negative) are tested in 3 different runs (only high shown here), by at least 2 different operators, in triplicate. In each run, an isotype control (e.g. Rb IgG, Ms IgG1, Ms IgG2a depending on primary antibody) is also tested as the negative control (bottom row).
Validated IHC Biomarkers
Discovery’s validated assays are developed, optimized, and rigorously tested for sensitivity, specificity, expression rate, precision and reproducibility to ensure dynamic and robust performance for your clinical trial or companion diagnostic programs.
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