Corgenix Medical Corporation was founded in Boulder, Colorado in 1990, with a focus on innovative autoimmune and other immunological assays for the clinical laboratory. In 1993, we initiated our first Contract Services program in collaboration with Chugai Pharmaceutical Co. Ltd. (now part of Roche Pharmaceuticals) to develop a next-generation platform test for assessing liver fibrosis in patients with Hepatitis C. That unique product significantly improved the Chugai test, and is still in production today, two decades later.

Since that first collaboration with Chugai, our Contract Services group has partnered with numerous other companies in various ways. Our business model is quite flexible, and each project and program is tailored to our partners’ needs. This might be a technology transfer that leads to the development of a next-generation version IVD, providing long-term manufacturing of a product in our FDA- and ISO 13485:2003 certified facility, providing assistance in securing regulatory clearances or approvals in the US, Canada, or Europe, and even order fulfillment and global commercialization for partners that lack that capability.

Examples of our projects

  • Developed next-generation IVD products in five (5) different testing platforms
  • Advanced a laboratory-developed product to RUO status and prepared for global launch
  • Developed and secured regulatory clearance for a novel rapid test for Lassa viral hemorrhagic fever
  • Developed next-generation rapid and laboratory tests for Ebola and Marburg viruses using recombinant technology
  • Provided production and fulfillment support of one of the fastest-growing cardiac disease IVD products
  • Transferred technology and manufactured controls for a point-of-care women’s health product
  • Managed IVD product distribution fulfillment and shipped our partner’s products worldwide from our facility in Colorado
  • Assisted in securing FDA clearance for a group of autoimmune products for an international partner
  • Assisted in securing CE Marking for a proprietary cardiac biomarker

For more than 20 years, we have provided contract services to large and small medical diagnostic and life science companies, universities, pharmaceutical companies, research institutions, and government agencies. Let us demonstrate our capabilities to make your program, project, or product a success.

If you would like to learn more about Corgenix Medical Corporation, or are interested in investment opportunities, please visit our corporate website at www.Corgenix.Com.