Chembio Diagnostics Inc, Medford, NY, a company that develops, manufactures, licenses, and markets proprietary rapid diagnostic tests, demonstrated its Dual Path Platform (DPP) technology, which enables development of point-of-care assays that provide features such as multiplexing and improved control of challenging sample types like oral fluid, at AACC. Chembio has submitted a premarket approval application with the U.S. Food and Drug Administration (FDA) for marketing approval of its DPP HIV 1/2 assay, a rapid point-of-care test for the detection of antibodies to HIV 1 and 2 in oral fluid, finger-stick whole blood, venous whole blood, and serum or plasma samplest. Chembio anticipates the PMA to be reviewed and approved by the FDA by the end of 2012. Several other tests have also been developed on this platform.
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