OraSure Technologies, Inc.
OraSure Technologies Provides Update on Clinical Development Programs and OraQuick Manufacturing
Published in Medical Letter on the CDC and FDA, July 12th, 2009
OraSure Technologies, Inc. (NASDAQ:OSUR) announced an update regarding the status of its application for U.S. Food and Drug Administration ("FDA") approval of an OraQuick® Hepatitis C ("HCV") test for professional use and its clinical program for an OraQuick® HIV-1/2 test for sale in the consumer or over-the-counter ("OTC") market. In addition, the Company announced its efforts to address manufacturing challenges recently experienced with respect to its OraQuick ADVANCE® rapid HIV-1/2 antibody test. OraQuick® HCV Test During the fourth quarter of 2008, the Company filed a premarket approval application ("PMA") with the FDA for approval of an OraQuick® HCV test for use in the professional...
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