Epitope OraQuick On-Site HIV Test U.S. Trials Expected To Start In July
This article was originally published in The Gray Sheet
Executive Summary
Epitope, Inc. says it will submit a premarket approval application for its OraQuick non-invasive, rapid, oral-fluid HIV-1/2 antibody test in January 2001.
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Firm files premarket approval application for the rapid HIV test, designed to detect antibodies within 20 minutes in oral fluid, whole blood, serum or plasma (1"The Gray Sheet" May 1, 2000, p. 17). The PMA covers serum and whole blood only. OraSure expects to file for use with oral fluid in the fourth quarter, upon completion of related trials
OraSure Technologies OraQuick
Firm files premarket approval application for the rapid HIV test, designed to detect antibodies within 20 minutes in oral fluid, whole blood, serum or plasma (1"The Gray Sheet" May 1, 2000, p. 17). The PMA covers serum and whole blood only. OraSure expects to file for use with oral fluid in the fourth quarter, upon completion of related trials
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Sponsors of rapid HIV test premarket approval applications should be allowed to use a multiple test algorithm to demonstrate sensitivity and specificity performance levels for diagnostic use, FDA's Blood Products Advisory Committee recommended at a June 15 meeting in Silver Spring, Maryland.