OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that it 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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“We are very pleased to have had the opportunity to discuss our ongoing clinical efforts for an at-home HIV test with the Blood Products Advisory Committee,” said Douglas A. Michels, President and CEO of OraSure Technologies. “The meeting was productive and very informative. We are gaining greater clarity as to the additional steps for this clinical program and intend to work closely with the FDA to define and execute the remaining studies required for approval.”
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.
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