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news.Filed PMA with FDA for approval of OraQuick HCV test, for use in professional market
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OraSure has provided update regarding the status of its application for FDA approval of an OraQuick Hepatitis C (HCV) test, and its clinical program for an OraQuick HIV-1/2 test for sale in over-the-counter (OTC) market.
In addition, the company announced its efforts to address manufacturing challenges, recently experienced with respect to OraQuick advance rapid HIV-1/2 antibody test.
The company has filed a premarket approval application (PMA) with the FDA, for approval of OraQuick HCV test for use in the professional market. The company also said that it has submitted the results of the study to the FDA to obtain approval for OraQuick rapid HIV OTC test.
The study was stopped after testing was completed for the first 1,000 subjects, as data from the study met the success criteria initially established in the study protocol for this phase of the trials.