OraSure Technologies, Inc. Files Additional Data With FDA in Support of PMA Application for OraQuick Rapid HCV Test
Published: Jan 07, 2010
BETHLEHEM, Pa., Jan. 7, 2010 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today the recent filing of a pre-market approval ("PMA") amendment with the U.S. Food and Drug Administration ("FDA") for the Company's OraQuick(R) Rapid HCV Antibody Test. The amendment contains additional clinical data requested by the FDA for use of the test in detecting antibodies to the Hepatitis C Virus ("HCV") in venous whole blood samples.