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

ct.  During October 2011 we received CE Marking for this product and this is allowing us to start commercializing it outside the United States.

Sure Check HIV for Consumer Self-Testing -- In September 2011, the Company received clarification from the Food and Drug Administration for the regulatory requirements for the Sure Check® HIV 1/2 rapid test for sale over-the-counter (OTC).  Additional studies are required for submission of an Investigational Device Exemption (IDE) as the first step toward product approval.  We believe these studies can be completed by the end of the first quarter of 2012 at which time we would submit our IDE to the FDA.

RESEARCH & DEVELOPMENTDPP® Leptospirosis -- We have approximately nine months left of the three-year $3 million Small Business Innovative Research (SBIR) Phase II grant we were awarded in 2009 by the United States National Institutes of Health (NIH) to fully develop, validate, and commercialize a rapid diagnostic test for Leptospirosis for general use worldwide.  Our work pursuant to this grant is progressing on schedule. The test will be developed with our DPP® technology and will utilize proprietary reagents developed by Yale University and the Oswaldo Cruz Foundation at the Brazilian Ministry of Health.  Development of the test will be in collaboration with the Division of Infectious Diseases, Yale University in New Haven, CT and the Oswaldo Cruz Foundation, the largest biomedical research institution in Latin America.

DPP® Tuberculosis -- As reported in February 2011, we were awarded a three-year $2.9 million, subsequently reduced to $2.4 million, Small Business Innovative Research (SBIR) Phase II grant from the United States National Institutes of Health (NIH) to continue development of a simple, rapid, accurate, and cost-effective serological test for active tuberculosis that can be utilized in resource-limited settings.  '/>"/>

SOURCE Chembio Diagnostics, Inc.
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