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Chembio’s DPP® Zika System Including the DPP® Micro Reader Approved by Brazil’s Health Regulatory Agency

MEDFORD, N.Y., July 05, 2017 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced that it has received approval for commercial use in Brazil of its DPP® Micro Reader by the Brazilian health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA), in collaboration with Bio-Manguinhos/Fiocruz.

With this latest ANVISA approval, Chembio’s DPP® Zika System, which includes the DPP® Zika IgM/IgG Assay and DPP® Micro Reader, is now approved for commercial use in Brazil.

The DPP® Zika IgM/IgG Assay detects antibodies using a tiny (10uL) drop of blood from the fingertip and provides quantitative results in 15 minutes, when used with the handheld, battery-operated DPP® Micro Reader.

Sharon Klugewicz, Chembio's acting CEO, commented, "We are pleased to receive ANVISA approval for commercial use of the DPP® Micro Reader and look forward to commercializing our DPP® Zika System in Brazil. In recent months, we have achieved several important pre-commercial milestones. Previously, we received approval of the DPP® Zika IgM/IgG Assay by ANVISA, as well as a successful evaluation of the DPP® Zika System by Brazil’s National Institute for Quality Control in Health (INCQS); and we now have received approval of the DPP® Micro Reader by ANVISA. In collaboration with Bio-Manguinhos, we can now shift our focus to commercial activities.”

In 2016, Chembio announced its Zika collaboration with Bio-Manguinhos, a...