We offer orthogonal validation to meet analytical validation requirements for regulatory filings. As a CDO (diagnostic-focused CRO), our team of experts have experience designing and executing studies to compare an assay with an independently validated orthogonal method for analytical accuracy/concordance, as well as 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.)
ResearchDx has performed over 50 different studies involving orthogonal comparator methods in support of demonstrating analytical accuracy as well as a head-to-head comparison study against the gold standard solution for product launch validation or as a marketing piece.
Orthogonal Comparator Methods
- Various validated NGS Panels (different sizes as well as custom)
- 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 kitted solution
Schedule a consultation with our research team to discuss your specific needs.