OraSure eyes early 2008 FDA filing for "first" rapid oral HCV test
This article was originally published in Clinica
Executive Summary
OraSure expects to file in early 2008 for US FDA approval for its OraQuick HCV test, which it hopes will be the first rapid hepatitis C virus (HCV) antibody test to reach the US market. The Bethlehem, Pennsylvania company plans to begin clinical studies of the technology "over the next several months".