Corgenix Files Concurrent de novo 510(k) Pre-Market Notification for FDA Clearance of its Hyaluronic Acid (HA) Test Kit

Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, announced today it has filed pre-market notification to the FDA pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for its Hyaluronic Acid (HA) ELISA Test Kit.

The submission follows the completion of a clinical study conducted by Corgenix and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) under a cooperative research and development agreement (CRADA).

The study assessed the Corgenix Hyaluronic Acid (HA) Test Kit as a marker for liver fibrosis in nonalcoholic steatohepatitis (NASH) patients. NASH patients are typically diagnosed using invasive liver biopsy procedures. The Corgenix-NIDDK study was 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 two to five percent of the U.S. population has NASH.

The safety and efficacy of the HA Test Kit has not yet been evaluated by the U.S. Food and Drug Administration.