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Biotech / Medical : Biotech Valuation
CRSP 55.26+1.2%3:59 PM EST
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From: greenehugh2/22/2005 3:57:13 PM
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CEMI Added. Target $2 if it gets FDA approval. Due your own DD. "Chembio Submits Two HIV Rapid Tests to the FDA for Pre-Market Approval; Products Also Qualified for USAID and UN Global Fund Procurements

MEDFORD, NY--(BUSINESS WIRE)----Chembio Diagnostics, Inc. (OTCBB:CEMI) today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Pre-Market Approval of its Sure Check(TM) HIV and HIV Stat-Pak rapid HIV tests. Both Sure Check HIV and HIV Stat-Pak are rapid test devices that can detect antibodies to the HIV virus within 15 minutes using finger stick whole blood samples. The FDA submittal, which also includes claims for venous whole blood, serum and plasma samples, was made on February 17th.

Chembio also announced that it has been notified by the World Health Organization (WHO) and the United States Agency for International Development (USAID) that its HIV rapid tests have qualified for procurements pursuant to the WHO Bulk Procurement Scheme and the USAID "Waiver" List pending FDA approval. These qualifications enable Chembio to participate in procurements under the United States $15 Billion President's Emergency Plan for AIDS Relief (PEPFAR), the UNAIDS Global Fund for HIV, TB & Malaria and other agency procurements affiliated with these major programs worldwide. These qualifications are as a result of evaluations that the United States Centers for Disease Control and Prevention and the World Health Organization performed with Chembio's HIV rapid tests during 2004."

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