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Chembio Reports 3rd Quarter 2011 Results
Date:11/3/2011

gh the Oswaldo Cruz Foundation (FIOCRUZ) -- During 2010 we received notification from FIOCRUZ that our DPP® HIV 1/2 screening test and our DPP® HIV confirmatory test were each approved by Brazil's National Health Surveillance Agency (ANVISA).  During 2011 our DPP® visceral canine leishmania ("VL") rapid test was approved by Brazil's Ministry of Agriculture, Livestock and Food Supply ("MAPA"). This is the first diagnostic product that FIOCRUZ has successfully submitted for approval to MAPA.  In addition, FIOCRUZ received the required approval from ANVISA for the DPP® Syphilis-Treponemal test and the DPP®-Leptospirosis test.  The submission for the DPP® multiplex Syphilis Treponemal-Non-Treponemal has not yet occurred.

FDA Approval for DPP® HIV 1/2 Screening Assay -- We began submitting the PMA (Pre-Marketing Approval) application using the Modular PMA option, and we have thus far submitted Module I containing manufacturing information and Module II containing non-clinical data, which was submitted in the beginning of October 2011.  We have experienced some delays in completing the clinical trials, which are the main component for the final Module III.  We now expect to finish the clinical trials during the fourth quarter of 2011. As of October 31, 2011 we have completed approximately 90% of the 3,000-patient clinical trials. We believe that the results of the clinical trials thus far indicate that the sensitivity and specificity of this product on all matrices meets or exceeds the performance requirements for FDA approval. However the trials are not complete and there can be no assurance that the FDA will agree with our assessment.  

DPP® Syphilis Screen & Confirm -- We are engaged in a number of activities oriented to commercializing this product.  We have commenced testing at the first of three sites in support of our planned 510(K) clearance of this produ
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SOURCE Chembio Diagnostics, Inc.
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