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.