OTC HIV Tests
This article was originally published in The Gray Sheet
Executive Summary
FDA's Blood Products Advisory Committee will meet for a second time March 10 to discuss clinical trial requirements for over-the-counter HIV testing. OraSure, which markets the OraQuick Advance Rapid HIV-1/2 antibody test, hopes that the meeting will allow the firm to begin "more detailed planning for the initiation of trials later this year" to support over-the-counter use of the test, CEO Douglas Michels said during an earnings call Feb. 9. OraSure presented at the Nov. 3 BPAC meeting (1"The Gray Sheet" Nov. 7, 2005, p. 12)...