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.)

 

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
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.
Schedule a consultation with our research team to discuss your specific needs.
About Research Dx
ResearchDx is a full-service diagnostic development organization, providing a ‘start-finish’ partnership for the co-development of companion diagnostics.  At RDx, we design, manage, de-risk and coordinate every aspect of the diagnostics development process, from biomarker discovery, assay design and validation, clinical trial management and logistics, and regulatory submission. As a uniquely technology and platform agnostic solutions provider, we look at all available options to best support your project.
As your single CLIA, CAP and ISO13485 certified partner, we understand the challenges of CDx development and strive to provide a cost effective, de-risked path and clear strategic guidance. RDx provides a flexible process that is agile and adaptable and we dedicate ourselves to the success of our partners.