Chembio Diagnostics, Inc. (OTCBB: CEMI), a company that develops, manufactures, licenses, and markets proprietary rapid diagnostic tests, announced today that it will present at a meeting of the Blood Products Advisory Committee ("BPAC") of the U.S. Food and Drug Administration ("FDA") in Bethesda, Maryland, on the afternoon of November 17, 2009. The agenda of the committee will include the public health need and performance characteristics of over-the-counter ("OTC") home-use HIV test kits.
Chembio's presentation will be made by Louise Sigismondi, Ph.D., Director of Regulatory Affairs at Chembio, who will cover certain characteristics of Chembio's DPP® HIV 1/2 Screening Assay, particularly those which could make it suitable as an OTC HIV test kit intended for home use. This product is a rapid, qualitative screening assay for the detection of antibodies to HIV 1 & 2 in oral fluids, whole blood, serum or plasma. The simple-to-use test offers a very reliable result within minutes of administration and it can be safely stored at room temperature for up to 24 months before use, making it ideal for the OTC market. Chembio intends to seek regulatory approval for this product for the professional market in the U.S. during 2010. Depending on various factors, including the FDA requirements, Chembio intends to begin seeking OTC approval of this product in 2011.
Lawrence Siebert, CEO of Chembio, said, "Possible U.S. OTC approval of this test opens up a new potential market for our products, one that should help identify those HIV-positive individuals in the U.S. who are unaware of their status, and we look forward to providing the BPAC with information about our technology and to receiving further guidance from BPAC regarding the requirements for obtaining approval of this product in the OTC market."
Further information concerning this meeting can be accessed at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM189020.pdf.
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