Companion diagnostics start off as research assays, often developed in early phase or preclinical development. A well-functioning predictive biomarker, however, may not make a good companion diagnostic unless it is compatible with modern clinical laboratory practices. Care and consideration are required to ensure that a CTA or potenital CDx assay is amendable to scalable deployment, regulatory approval, and eventual commercial launch.

NeoGenomics utilizes a platform agnostic approach for assay development. We have established with most large IVD Manufacturers including preferred provider relationships and extensive experience with their platforms and reagents. We frequently bridge research grade assays to CTAs that are amenable to global deployment and eventual commercialization.

A team of scientific liaisons is available to provide guidance on platform selection to ensure that CDx projects are placed on IVD-capable equipment and utilize reagents that can be produced to GMP standards. Technology choice is important, as some platforms are more readily commercialized than others. Established technologies provide access to established IVD partners with established commercial footprint and regulatory expertise. Furthermore, regulatory agencies have a strong preference for well-characterized platforms and technologies. In terms of established technologies, IHC, FISH, PCR, and NGS are well accepted. Flow cytometry and multiplex immunofluorescence assays are gaining in acceptance.

NeoGenomics can support the following approaches for CDx development with many IVD-capable platforms for CDx development.

IVD Orthogonal Testing

NeoGenomics offers multiple FDA-cleared diagnostics that can be utilized for orthogonal accuracy studies. Our list of assays is constantly being updated, so please reach out directly to NeoGenomics for the most current options. Tests include:

  • ALK (IHC and FISH)
  • BRAF (ThxID, cobas)
  • EGFR (cobas, RGQ)
  • FGFR (RGQ)
  • HER2 (IHC and FISH)
  • IDH1/2 (Abbott M2000)
  • KRAS (RGQ)
  • Nanostring Prosigna
  • PDL1 (22c3, 28-8, SP142, and SP263 clones available)
  • PIK3CA (RGQ)
  • Oncomine (Thermo Fisher)
  • Vysis CLL