ORASURE SAYS BPAC OF FDA PLANS TO SET FORTH CLINICAL STUDY REQUIREMENT FOR HOME USE HIV KIT
OraSure Technologies Inc., a provider of oral specimen collection devices, said that the
Blood Products Advisory Committee or BPAC of FDA endorsed and provided a regulatory
pathway for approval of an over-the-counter rapid home use HIV test kit. At a
discussion held on March 10, 2006 on Gaithersburg the committee approved to set
forth clinical study requirements for consent of home use HIV test kit. The proposal
was originally put forward by Food and Drug Administration.