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

Chembio Diagnostics, Inc.(Nasdaq: CEMI),a leader in point-of-care diagnostic tests for infectiousdiseases, announces receipt of approval from the U.S. Food and DrugAdministration (FDA) to market the Company's Dual Path Platform^® (DPP^®) HIV1/2 assay for the rapid, point-of-care (POC) detection of HIV-1/2 antibodiesin either oral fluid or blood samples. This determination follows a review ofChembio's Premarket Approval (PMA) application and marks the first FDAapproval of a diagnostic assay utilizing the Company's patented Dual PathPlatform^® technology. DPP^® enables samples to bind directly with targetanalytes before detection reagents are introduced to visualize the testresults, and can improve accuracy compared with the current lateral flow HIVtest technologies.