Orthogonal Validations
We offer orthogonal validation to meet analytical validation requirements for regulatory filings. As a CDO (diagnostic-focused CRO), our team of experts has experience designing and executing studies to compare an assay with an independently validated orthogonal method for analytical accuracy/concordance and platform validation.
ResearchDx can help with study design, representative sample selection, study execution, statistical analysis, reporting and GAP analysis to satisfy relevant regulatory requirements. Our clients include many of the biggest names in diagnostics.
We offer externally validated solutions across different technology types (NGS, Sanger, qPCR, ddPCR, FISH, etc.)
Orthogonal Comparator Methods
- Multiple validated NGS Panels
- Sanger Sequencing
- qPCR – Commercial and custom solutions
- ddPCR – Commercial and custom solutions
- ELISA – Commercial and custom solutions
- FACS – Custom solutions to fit your needs
- Any commercially available assay, reagent or Kit.
Product Focus: PMA and 510(k) Reproducibility Studies
ResearchDx has performed hundreds of studies on behalf of our clients. A selection of our expertise includes:
- Diagnostic Equipment Precision/Reproducability studies, with comparison to orthogonal device
- Diagnostic Assay Precision/Reproducibility studies with comparison to orthogonal assay
- Custom-developed orthogonal assays for unique and bespoke assay application
ResearchDx has performed dozens of different studies involving orthogonal comparator methods in support of IVD submissions, demonstrating analytical accuracy, product launch validation and for comparative marketing purposes.