Found a good article on MIRIf any of you have access to a university library on-line, look up this article: "The Approval of Over-The-Counter HIV Tests: Playing Fair When Making the Rules"(2008) The author is Melissa Whellams (St. Mary's University). The article talks about Medmira and Orasure specifically and how they are, and have been for quite sometime, lobbying the FDA for approval. It deals with a number of issues that illustrate why things have taken so long and leaves you wondering when, if ever, OTC tests will be available.