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Eurofins Zika Test Receives FDA Emergency Use Authorization

NEW YORK (GenomeWeb) – Eurofins Scientific announced through its subsidiary Viracor-IBT Laboratories that the US Food and Drug Administration has granted emergency use authorization (EUA) for its test for the Zika virus.

The RT-PCR test detects Zika RNA in human serum, plasma, or urine collected from individuals meeting clinical or epidemiological criteria for Zika virus exposure. Missouri-based Viracor-IBT said in a statement that the test does not cross react with other Flaviviruses such as dengue or West Nile, or viruses causing similar symptoms such as chikungunya.

The firm said it will perform the assay at its CLIA certified and CAP accredited lab with a turnaround time of eight to 12 hours. The firm also said that test has been approved by the New York State Department of Health.

The Viracor-IBT test is the latest addition to a slew of Zika tests to receive EUA. As reported by GenomeWeb, tests developed by Hologic, Altona Diagnostics, Quest Diagnostics, and the US Centers for Disease Control and Prevention have all received the EUA label.

Ubiquitome and Siemens are also developing Zika tests with an application for EUA in mind.

Eurofins bought Viracor-IBT for $255 million in 2014.