OraSure's OraQuick is first rapid HCV test approved
This article was originally published in The Gray Sheet
Executive Summary
Firm gains PMA approval for its OraQuick hepatitis C virus (HCV) rapid antibody test, making it the first rapid HCV test on the U.S. market, the company announces June 25. "Getting faster treatment is an important public health step to control this dangerous disease," CDRH Director Jeffrey Shuren said in a same-day release. The test uses venous whole blood to provide results in about 20 minutes. Last summer, the firm said it would conduct additional clinical studies to satisfy concerns raised by FDA (1"The Gray Sheet" June 29, 2009). Under a previous collaboration deal, Merck will promote the test in the physicians' office market, OraSure notes