Partnership Results in New Diagnostic Test Kit

There’s a lot of power and potential in the right partnerships.

During this year’s Medica 2011 medical device trade fair in Dusseldorf, Germany, Cogenix Corgenix Medical Corp.—a developer of diagnostic test kits—launched its new hyaluronic acid (HA) immmunoturbidimetric test kit for use on automated chemistry analyzers.

The automated HA test kit is the first product to be released under a joint product development agreement signed in 2010 with the ELITech Group to co-develop new diagnostic tests. The new HA test kit will be available worldwide through ELITech and in the United States for research purposes only through Corgenix. It has not been cleared for use by the U.S. Food and Drug Administration (FDA).

“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,”said Corgenix President and CEO Douglass Simpson.

This is the second Corgenix product for measuring blood levels of hyaluronic acid. The first product is configured as an ELISA (enzyme-linked immunosorbent assay) micro-plate and has been available since 1998. It is CE Marked in the European Union to assess the degree of liver fibrosis and cirrhosis in chronic liver disease. The micro-plate product has not been cleared or approved by the FDA and is available for research use only—not for use in diagnostic procedures.

The new test kit is expected to be CE Marked for sale in the European Union within a few weeks.

Based in Denver, Colo., Corgenix makes specialized diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders, including the world’s only non-blood-based test for aspirin effect.

Aspirin, taken by millions of people every day to reduce the risk of heart attack and stroke, works by making blood platelets less sticky and thus less likely to form a blood clot. Clinical studies have shown that as many as one in four patients are not adequately protected by their aspirin therapy. A test developed by Corgenix determines the effect of aspirin on platelets by measuring the level of the biomarker called thromboxane B2. The higher the levels of thromboxane B2, the stickier the blood platelets and the less impact the aspirin is having. This information allows physicians to individualize a patient’s therapy, which may be as simple as adjusting the dose.

The ELITech Group is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. The company is headquartered in Puteaux, France.