The Corgenix Research & Development (R&D) team of researchers and laboratory professionals has over 100 years combined experience developing in-vitro diagnostic assays and their critical reagents. Our diverse background in product development includes Autoimmune Disease, Cardiovascular Disease, Clinical Chemistry, Sexually Transmitted Disease, Infectious Disease, Food Microbiology, and Biothreat Select Agents. We utilize our expertise in Formulation Chemistry and Design of Experiment to progress projects rapidly through the feasibility stage into Pre-Pilot optimization. Product development projects are fully integrated with our FDA- and ISO-approved phase-based Design Control system for seamless transition from development stages to manufacturing and commercialization. Our capabilities enable us to complete product development for our partners more quickly and cost-effectively.

Corgenix R&D has successfully commercialized over 50 IVD products for ourselves and our partners. While most of these diagnostic products are optimized in the ELISA format (both chromogenic and electrofluorescent) for high-throughput testing, we have also translated these tests into other diagnostic platforms. Our design and manufacturing capabilities include diverse technologies that span rapid Point-of-Care Testing (POCT) to Clinical Chemistry. Some of the areas we specialize in include:

  • Enzyme-linked Immuno Sorbant Assay (ELISA)
  • Rapid Diagnostic Tests (RDT)
  • Biosensors/Biochips
  • Immunoturbidimetry (ITA)

In addition to our assay development expertise, the Corgenix R&D Team also specializes in critical reagent development including Antigen and Biomarker Production, Antibody Reagent Development, Affinity Chromatography, Protein Chemistry, and Production Scale-up to provide a single-source assay development solution from the concept stage through product commercialization.