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.