First oral HIV test filed for approval:
This article was originally published in Clinica
Executive Summary
Epitope (US) has filed a premarket approval application with the US FDA to sell its Western Blot confirmatory HIV-1 test with its OraSure oral specimen collection device. The submission is the first in the US for an oral collection HIV-1 test, says the company, and follows clinical trials on 3,500 subjects at 14 sites around the world. Epitope is concentrating on diagnostics following its decision to divest its grape plant propagation and fresh flower businesses.