OraSure Technologies, Inc. (OSUR) announced the recent filing of a pre-market approval amendment with the U.S. Food and Drug Administration for its OraQuick 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, or HCV, in venous whole blood samples.
The company stated when approved for use with venous whole blood, the OraQuick HCV test is expected to be the first rapid HCV test approved by the FDA for use in the United States. The company is also currently completing an additional clinical study to obtain FDA approval of the OraQuick HCV test for use with oral fluid and fingerstick whole blood.
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