FDA Approves Emergency Use for Multiplex Zika Test

The Center for Infection and Immunity (CII) at Columbia University’s Mailman School today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the CII-ArboViroPlex rRT-PCR Test, the first multiplex assay that simultaneously tests for the presence of Zika virus, all serotypes of dengue virus, chikungunya virus, and West Nile virus, as well as a host gene that ensures the accuracy of results. Available for immediate use in clinical and research settings, the test was developed by CII scientists and an EUA application was submitted to FDA at the request of the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH) for use in its multi-country Zika in Infants and Pregnancy (ZIP) study.

“The ArboViroPlex Test provides an easy and efficient means to simultaneously detect Zika and three other mosquito-borne viral infections that may present with similar clinical features,” says Nischay Mishra, the lead project scientist and associate research scientist at CII.

“The FDA decision to issue the EUA gives clinicians and researchers a powerful tool to diagnose and prevent the spread of Zika,” adds W. Ian Lipkin, director of CII and the John Snow Professor of Epidemiology at the Mailman School of Public Health.

Lipkin, Mishra, and CII colleagues Thomas Briese and Rafal Tokarz are named on a pending international patent application for the technology.

Source: Columbia University Medical Center