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Chembio Diagnostics, Inc.
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.
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