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# Hologic Gains Emergency Use Authorization for Zika Assay
- URL: https://www.fdaweb.com/hologic-gains-emergency-use-authorization-for-zika-assay/
- Published: 2016-06-20T12:00:00.000Z
- Updated: 2026-09-14T21:10:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135988

FDA has granted Hologic an emergency use authorization for its new diagnostic assay for Zika virus infection, the Aptima Zika Virus assay. The molecular diagnostic tool allows for the qualitative detection of RNA from Zika virus in human serum and plasma specimens, according to the company. The assay runs on the Hologic Panther system that Hologic says automates all aspects of nucleic acid amplification testing. It is designed to be used in individuals meeting Centers for Disease Control and Prevention Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated).