Zika test receives FDA emergency use authorization
Hologic has received an emergency use authorization for the company's test for Zika virus infection.
The Marlborough company’s Aptima Zika Virus assay is a tool for detecting Zika RNA in human blood. The U.S. Food and Drug Administration (FDA) emergency use authorization is not FDA clearance or approval, but authorizes the use of the diagnostic tests as long as circumstances justify its use, according to Holigic.
The Aptima Zika Virus assay runs on the Hologic Panther system that automates the testing, thus minimizing the labor required and the potential for manual errors, according to the company. The test will be available for use in all 50 states, Puerto Rico and U.S. territories, expanding the number of public and private labs that can test for the virus. The test will be used on individuals meeting certain criteria, such as a history of residence in or travel to a geographic region with active Zika transmission at the time of travel.
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