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Chembio and Bio-Manguinhos Announce Plans to Introduce a Point-of-Care Diagnostic Test for Zika Virus in Brazil


Chembio Diagnostics, Inc. CEMI, +0.69% a leader in point-of-care (POC) diagnostic tests for infectious diseases, today announced the status of its plans with Bio-Manguinhos/Fiocruz to obtain regulatory approval and to introduce a POC diagnostic test for Zika virus in Brazil. The announcement coincides with the 40th anniversary of Bio-Manguinhos, which was recognized at the Third International Symposium of Immunobiologicals, held May 2-5, 2016 in Rio de Janeiro, Brazil.

Bio-Manguinhos is the unit of the Oswaldo Cruz Foundation (Fiocruz) responsible for development and production of vaccines, diagnostics and biopharmaceuticals, primarily to meet the demands of Brazil's national public health system. Over the last 12 years, Chembio and Bio-Manguinhos have successfully collaborated to develop and commercialize a number of POC diagnostics, including tests for HIV, Syphilis, and Leishmania.

Since announcing its initial Zika collaboration with Bio-Manguinhos in March 2016, Chembio has made significant progress toward the commercialization of the DPP [(R)] Zika IgM/IgG Assay in Brazil, including the following:

  • Developed DPP [(R)] Zika IgM/IgG Assay in Chembio's Research & Development facilities.
  • Conducted tests of DPP [(R)] Zika IgM/IgG Assay with nearly a thousand clinical samples from Brazil, Colombia, Dominican Republic, El Salvador, Malaysia, Mexico and the United States.
  • Submitted application for approval of DPP [(R)] Zika IgM/IgG Assay and DPP [(R)] Micro Reader with the Brazilian regulatory agency, Ag�ncia Nacional de Vigil�ncia Sanit�ria (ANVISA).
  • Established commercial terms with Bio-Manguinhos, to supply DPP...