NEW YORK (360Dx) – Chembio Diagnostics said today it has received US Food and Drug Administration emergency use authorization (EUA) for its DPP Zika System.
The authorization makes the test available for use in high- and moderate-complexity CLIA-certified laboratories.
Under the EUA, the diagnostic can be used to test subjects meeting Centers for Disease Control and Prevention Zika virus clinical and/or epidemiological criteria. The system uses the company's DPP Micro Reader to detect Zika virus IgM antibodies in fingerstick whole blood.
"We believe the deployment of a rapid test for the presumptive detection of human IgM antibodies to Zika virus will be a critical tool in dealing with the ongoing spread of Zika virus, and we plan to make the DPP Zika System immediately available in the US, Puerto Rico, and the US Virgin Islands," Chembio Acting CEO Sharon Klugewicz said in a statement.
Chembio has received a $5.9 million contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop and obtain regulatory clearance for the Zika System and its DPP Zika/Dengue/Chikungunya System, and could receive up to $13.2 million in total funding.