Enzo Biochem today announced that the New York State Department of Health has granted approval of its AmpiProbe-HCV assay for quantitative detection of Hepatitis C virus.
 

AmpiProbe is the firm's proprietary nucleic acid amplification and detection platform developed by scientists at the New York-based company. The approval means the firm can offer its test to residents of the state of New York.
 

"The approval of AmpiProbe-HCV is an important milestone for our business," Enzo CEO Elazar Rabbani said in a statement. "Given the ever increasing reimbursement pressures on the nation's clinical laboratories, we expect this product as well as other products emerging from Enzo's platforms, including AmpiProbe, to have a significant impact on the market as these labs seek low-cost, innovative solutions."

              
Enzo said in a statement that the assay was shown to detect HCV at a level as low as 5.5 International Units per ml of serum with a positive rate greater than 95 percent, while the limit of quantification was 10 IU/ml, which is more sensitive than leading commercially available assays in the US. Moreover, the assay uses less sample material than leading tests currently offered in clinical laboratories, allowing for additional testing from the original sample.