In Brief: Epitope
This article was originally published in The Gray Sheet
Executive Summary
Epitope: Plans to submit a premarket approval application "by mid-June" for use of a modified Western blot HIV confirmatory test with Orasure specimens. Epitope's PMA for the Orasure oral specimen HIV diagnostic received FDA approval in December 1994 ("The Gray Sheet" Jan. 2, 1995, p. 1)...