OraSure OraQuick HIV Blood Test Launch Expected In Latter Half Of 2002
This article was originally published in The Gray Sheet
Executive Summary
OraSure anticipates FDA approval of its OraQuick fingerstick whole blood rapid HIV-1 test by mid-May
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OraSure OraQuick
Rapid HIV-1 antibody test is deemed "approvable" by FDA pending resolution of "specific validation and control issues" detected during a recent agency inspection of the firm's manufacturing facilities, OraSure announces May 13. The test can detect HIV-1 antibodies in whole blood via a finger stick within 20 minutes (1"The Gray Sheet" May 6, 2002, p. 42). A market launch is slated for the second half of the year...
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