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Chembio Receives Brazilian Regulatory Approval for Zika Micro-Reader

NEW YORK (360Dx) – Chembio Diagnostics today said that the Brazilian health regulatory agency Agência Nacional de Vigilância Sanitária (ANVISA) approved the commercial use of the firm's DPP Micro Reader in that country, in collaboration with Bio-Manguinhos.

Chembio noted that because of the approval, its DPP Zika System, which includes a Zika IgM/IgG assay along with the micro reader, is also cleared for commercial use in Brazil.

Chembio's Zika IgM/IgG assay detects antibodies using a 10 microliter fingerstick sample of blood, and provides quantitative results in 15 minutes when it is used with the micro reader, a handheld device powered by a battery.

Chembio's acting CEO Sharon Klugewicz said in a statement that the approval for the micro reader is one of "several important commercial milestones" received by the company in recent months. The firm has also received approval from ANVISA for its Zika IgM/IgG assay and "a successful evaluation" from Brazil's National Institute for Quality Control in Health of the firm's Zika system.

In 2016, Chembio announced a collaboration related to Zika testing with Bio-Manguinhos, a subsidiary of the Oswaldo Cruz Foundation, or Fiocruz. In May, Chembio said that it had received a $5.8 million order from Bio-Manguinhos/Fiocruz to supply test components and intermediate product to produce DPP HIV 1/2 Assays in Brazil, and for subsequent supply to Brazil's Ministry of Health.

Brazil was hit especially hard by the global Zika epidemic, which began in late 2015. According to Chembio, more than 2,300 cases of microcephaly, a neurological condition that has been tied to Zika infections in babies, have been confirmed in Brazil, with more than 3,000 cases under investigation.