Automated Corgenix Hyaluronic Acid Kit Receives CE Mark

Corgenix Medical Corporation has announced that its second generation Hyaluronic Acid (HA) Immunoturbidimetric Test Kit for use on automated chemistry analyzers, has received CE marking for commercialization in Europe. The kit measures blood levels of hyaluronic acid to assess the degree of liver fibrosis and cirrhosis in chronic liver disease.

The HA Test Kit is the second hyaluronic acid kit to have been produced by Corgenix, the first is an ELISA microplate which was commercialized in 1998. In 2010 Corgenix and ELITech entered into a Joint Product Development Agreement to co-develop new diagnostic test. The automated HA kit is the first product to be released as a result of that partnership.

“The CE marking of our automated HA product reaffirms our market leadership position in non-invasive biomarkers for assessing chronic liver disease and allows us to commercialize the product in Europe through our distribution partner ELITech,” 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 world markets.”

The product is available worldwide, including Europe, through ELITech. None of the HA products have yet received FDA clearance for diagnostic use in the U.S. although they available for research use through Corgenix.