November 19, 2009 (FinancialWire) — OraSure Technologies, Inc. (NASDAQ: OSUR) participated in a Blood Products Advisory Committee (BPAC) meeting held November 17, 2009 in which the BPAC considered, among other topics, the public need and performance characteristics for over-the-counter (OTC) home use HIV test kits.
The BPAC provides advice to the U.S. Food and Drug Administration (FDA) on issues related to the safety and effectiveness of biological products and medical devices.
During the November 17 meeting, a number of public presentations were made including with respect to the perspectives of the Centers for Disease Control and Prevention on the role of home use HIV test kits and the risks and benefits of home use HIV test kits. In addition, OraSure participated in a closed session with the BPAC in which OraSure reviewed the results of its ongoing clinical studies related to its OraQuick(R) HIV OTC test and the additional clinical work required for FDA approval. Based on feedback from the meeting, the company intends to continue its efforts to seek FDA approval of its OraQuick(R) HIV OTC test.
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