Rapid HIV Antibody Test Wins Approval Ahead of Licensing
Wall
Street Journal
April 24, 2004
The Food and
Drug Administration has given approval for OraSure Technologies Inc. to market
its OraQuick Rapid HIV-1/2 Antibody test, which allows simultaneous testing for
HIV-1 and HIV-2 in blood specimens. Previously, the test was approved only for
the detection of the Type 1 form of HIV.
The company said it obtained the approval in anticipation of receiving a
worldwide, non-exclusive license to certain HIV-2 patents held by Bio-Rad
Laboratories Inc., which it expects in the near future. In addition, OraSure is
seeking FDA approval of the OraQuick Rapid HIV-1/2 Antibody Test using oral
fluid and plasma samples.