The automated HA test kit marks the first product to be released under a Joint Product Development Agreement (JPDA) signed in 2010 with the ELITech Group to co-develop new diagnostic tests. The new HA test kit will be available worldwide through ELITech; it will be available in the U.S. for research purposes only through Corgenix.
"The launch of this new HA product reaffirms our market leadership position in non-invasive biomarkers for assessing chronic liver disease," said Corgenix President and CEO Douglass Simpson. "We have a very active development program with ELITech and over the next few years will be bringing additional new and exciting products to the global market."
This is the second Corgenix product for measuring blood levels of hyaluronic acid. The first product is configured as an ELISA microplate and has been commercialized worldwide since 1998. It is CE marked for the European Union to assess the degree of liver fibrosis and cirrhosis in chronic liver disease. The microplate product has not been cleared or approved in the U.S. by the Food and Drug Administration (FDA) and is available for research use only (not for use in diagnostic procedures).
The Corgenix Hyaluronic Acid Immmunoturbidimetric Test Kit is expected to be CE-marked for sale in the European Union within a few weeks. In all countries where the use of this product has not been cleared by local regulating agencies, the products shall not be used for diagnostic use as the performance characteristics have not been established. Corgenix Hyaluronic Acid Immmunoturbidimetric Test Kit is not FDA cleared or approved for diagnostic use in the U.S.
About Corgenix Medical Corporation
Corgenix is a leader in the development and manufacturing of specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the worlds only non-blood-based test for aspirin effect. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network. More information is available at www.corgenix.com.
About the ELITech Group
The ELITech Group is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITech Group has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient. The ELITech Group manufactures and distributes diagnostic products for clinical chemistry, microbiology, immunology, and molecular biology though direct sales and a distribution network encompassing more than 100 countries. More information is available at www.elitechgroup.com.