Brazil’s health regulatory agency ANVISA approves diagnostic test for Zika virus


The Brazilian health regulatory agency Agência Nacional de Vigilância Sanitária (ANVISA) has approved a diagnostic test DPP Zika IgM/IgG Assay for detection of the Zika virus infection. The test is developed by Chembio Diagnostics, a leader in point-of-care (POC) diagnostic tests for infectious diseases. Chembio collaborated with Bio-Manguinhos in March 2016 for development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet demands of Brazil’s national public health system. Chembio collaborated with Bio-Manguinhos/Fiocruz in May 2016 to obtain regulatory approval and to introduce a POC diagnostic test for the Zika virus in Brazil. Chembio is involved with INCQS, Brazil’s National Institute for Quality Control in Health and ANVISA to accomplish final steps of commercial release of the product. Brazil has been hardest hit by the Zika virus, where 1.5 million people have been infected with Zika virus and 2,000 babies have been born with microcephaly, a devastating birth defect linked to the Zika virus.

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