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Chembio Diagnostics Announces FDA Approval for DPP Point-of-Care HIV 1/2 Rapidi Test

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Chembio Diagnostics, Inc. (Nasdaq: CEMI),a leader in point-of-care diagnostic tests for infectious diseases, announces receipt of approval from the U.S. Food and Drug Administration (FDA) to market the Company's Dual Path Platform^® (DPP^®) HIV 1/2 assay for the rapid, point-of-care (POC) detection of HIV-1/2 antibodies in either oral fluid or blood samples. This determination follows a review of Chembio's Premarket Approval (PMA) application and marks the first FDA approval of a diagnostic assay utilizing the Company's patented Dual Path Platform^® technology. DPP^® enables samples to bind directly with target analytes before detection reagents are introduced to visualize the test results, and can improve accuracy compared with the current lateral flow HIV test technologies.

Posted-In: News FDA


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