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Medical News

OraSure Applies for Approval of Rapid HIV Test

From U.S. Centers for Disease Control and Prevention

September 30, 2003

Bethlehem, Pa.-based OraSure Technologies Inc. said it was applying Monday to the U.S. Food and Drug Administration for pre-market approval of its OraQuick rapid test for use in detecting HIV antibodies in saliva or plasma samples. "This filing is the next major step in our efforts to expand the versatility of the OraQuick test," said OraSure CEO Mike Gausling. The OraQuick test was the first rapid, point-of-care test approved by the FDA to detect HIV antibodies in blood specimens -- giving results in about 20 minutes. FDA approval for testing saliva or plasma would broaden the appeal of the test by providing advantages over competing blood or urine HIV tests, said Gausling.

Back to other news for September 30, 2003

Adapted from:
Associated Press
09.29.03

  
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This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
 
 

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