Corgenix Medical enters development agreement wth NIH

Dec 18 2007

Corgenix Medical Corporation has announced it has entered into a corporative research and development agreement (CRADA) with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH).

The two-year study will use the Corgenix Hyaluronic Acid (HA) test kit alone and in combination with other liver fibrosis biomarkers, to develop a predictive model for liver fibrosis in nonalcoholic steatohepatitis (NASH) patients. NASH patients are typically diagnosed using invasive liver biopsy procedures. The Corgenix-NIDDK study is focused on developing a non-invasive method of diagnosis.

Nonalcoholic fatty liver disease (NAFLD) is a chronic, typically mild liver condition associated with obesity and insulin resistance, characterized by the presence of fat in the liver. Currently recognized as the most common cause of chronic liver disease in the U.S., NAFLD affects 20-24 percent of Americans. Nonalcoholic steatohepatitis (NASH) is an advanced form of NAFLD associated with inflammation and damage to the liver that can progress to fibrosis and cirrhosis. Approximately 2-5 percent of the U.S. population has NASH.

Since NASH carries a high risk of portal hypertension, liver failure requiring liver transplantation, and hepatocellular carcinoma, it is important to identify these individuals for prognostic and patient management decisions. Currently, the only reliable way to distinguish between NAFLD and NASH is by liver biopsy, which is costly (especially when considering that 60 – 75 million individuals in the U.S. have NAFLD), painful and carries some risk to patients. The aim of this study is to identify non-invasive, reliable markers to identify patients at risk for NASH.

“ We are very excited about our collaboration with the NIH. This is a definitive study that will apply our HA product to a very important and clearly under-diagnosed condition that affects a significant percentage of the U.S. population, ” said Corgenix President and Chief Executive Officer Douglass Simpson. “ With the rate of obesity in the U.S. continuing to increase, the prevalence of NASH will increase as well, and it will be even more important to have effective, non-invasive methods for assessment. ”

“ Nonalcoholic steatohepatitis is a major healthcare problem. It is typically a ‘ silent ' disease with few or no symptoms until the disease is advanced, ” said Luis Lopez, M.D., Corgenix Chief Medical Officer. “ NASH patients whose disease has progressed to cirrhosis have a 7-10 year mortality of up to 25 percent. We believe this study has the potential to make a major difference in literally millions of individuals when completed. ”

The Corgenix Hyaluronic Acid test kit has not been cleared by the U.S. Food and Drug Administration for in vitro diagnostic use in the United States. 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. The Hyaluronic Acid test kit is CE-marked for sale in the European Union.