In Brief: Epitope
This article was originally published in The Gray Sheet
Executive Summary
Epitope: Submits premarket approval application to FDA for its HIV-1 Western Blot confirmatory test for use in conjunction with the OraSure oral specimen collection device, the firm announces June 14. The submission follows completion of clinical trials with over 3,500 patients at 14 sites in the U.S. OraSure collection device was approved in December 1994 for HIV screening using an oral sample ("The Gray Sheet" Jan. 2, p. 1). The firm submitted a 510(k) in February for use of OraSure in cocaine testing...