The US Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) will consider the OraSure Technologies Inc‘s application for the approval of its OraQuick Rapid HIV-1/2 test for sale in the US consumer or over-the-counter (OTC) market at a meeting scheduled for May 15, 2012.
The company will be presenting the findings from the final phase of clinical testing, which involved the use of the OraQuick In-Home HIV Test, an OTC investigational use version of the OraQuick ADVANCE Rapid HIV-1/2 test, by individuals in an unobserved setting. Approximately 5,800 subjects were enrolled and tested in this phase across 20 sites nationwide, resulting in the identification of more than 100 previously undiagnosed individuals with HIV.
"There is an urgent need for additional testing options to identify individuals who are HIV-positive, link them to care, and reduce transmission of the virus," said Douglas A. Michels, president and CEO of OraSure Technologies. "Our belief is that the availability of an easy-to-use, accurate in-home HIV test will enable more people to learn their presumptive HIV status so that they can receive necessary care and support."
The meeting notice for the Blood Products Advisory Committee meeting is scheduled for publication in the Federal Register on April 5.
OraSure currently manufactures and sells the OraQuick ADVANCE Rapid HIV-1/2 Test which is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in oral fluid in 20 minutes. OraQuick ADVANCE is used extensively throughout the US in public health settings, hospitals, community-based organizations, and physician offices where HIV testing is conducted. The OraQuick In-Home HIV Test is an over-the-counter version of the OraQuick ADVANCE product currently sold into the professional market.
Source: OraSure Technologies
