Corgenix Medical, a developer of diagnostic test kits, has filed pre-market notification with the US Food and Drug Administration under Section 510(k) of the US Federal Food, Drug and Cosmetic Act for its hyaluronic acid (HA) enzyme-linked immunosorbent assay (ELISA) test kit.

This filing follows the successful completion of a clinical study conducted by the company 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 HA ELISA test kit as a marker for liver fibrosis in nonalcoholic steatohepatitis patients.

Invasive liver biopsy procedures are being used to diagnose nonalcoholic steatohepatitis patients.

The Corgenix-NIDDK study was focused on developing a non-invasive method of diagnosis.

Nonalcoholic fatty liver disease is a chronic mild liver condition associated with obesity and insulin resistance, characterized by the presence of fat in the liver.

The FDA has yet to evaluate the safety and efficacy of the HA ELISA test kit.