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