Companion Diagnostics (CDx)

Companion Diagnostics (CDx) are designed to assist physicians in determining whether a patient might benefit from a particular therapy. Companion Diagnostics can be configured on many platforms and takes advantage of molecular- or protein-based biomarkers that identify or track disease presence and progression.

In 2013, Corgenix entered into a collaboration with a top 15 Pharma Company for the development of ELISA diagnostics. Today our business focus is centered on developing Protein Companion Diagnostics.

We offer the following services to our CDx partners:

  • Critical reagent development and characterization
  • Identification of appropriate analytical platform(s)
  • Feasibility studies
  • RUO kit generation
  • RUO-to-IUO conversion
  • Correlation studies
  • Regulatory support/submissions for IUO and IVD stages, with a strategic focus on determining the least burdensome path to market.
  • Post-approval commercialization and life-cycle management