bioMérieux Vironostika
This article was originally published in The Gray Sheet
Executive Summary
Retrovirus firm will launch HIV-1 Plus O Microelisa system in late 2003 or early 2004 for qualitative detection of HIV-1 antibodies, including Group O, in serum and plasma, following earlier than expected CBER-reviewed PMA approval June 6. Yielding 100% sensitivity and specificity, the test is the first to gain approval since FDA requested a Type O diagnostic in 1996 (1"The Gray Sheet" July 22, 1996, I&W-11)...