Corgenix Medical entered into a corporative research and development agreement (CRADA) with the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK).
The two-year study will use 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 noninvasive method of diagnosis.
“This is a definitive study that will apply our HA product to an important and clearly underdiagnosed condition that affects a significant percentage of the U.S. population,” says Corgenix president and CEO 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, noninvasive methods for assessment.”
The Corgenix Hyaluronic Acid test kit has not been cleared by the FDA for in vitro diagnostic use in the U.S., but it is CE-marked for sale in the European Union.