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 non-alcoholic steatohepatitis (NASH) patients.
NASH patients are typically diagnosed using invasive liver biopsy procedures. The Corgenix-NIDDK study is focused on developing a noninvasive method of diagnosis.
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,” Simpson added.
“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,” said Lopez.