FDA gives emergency approval of Aptima Zika Virus assay for Zika Virus diagnosis- Hologic

The FDA has granted emergency use authorization for the Aptima Zika virus assay system, from Hologic, for detection of the Zika Virus. The Aptima Zika Virus assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

The Aptima Zika Virus assay runs on the Hologic Panther system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. The Panther system substantially reduces hands-on time for laboratories, minimizing the labor required and the potential for manual errors. The Aptima Zika Virus assay is designed to be used in individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests, or by similarly qualified non-U.S. laboratories.