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Thermo Fisher Zika Test Gets FDA Emergency Use Authorization

NEW YORK (GenomeWeb) – The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.

The kit is authorized to be conducted by CLIA-certified labs in the US only for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection in human serum and urine collected alongside a patient-matched serum specimen. Individuals receiving the test must meet US Centers for Disease Control and Prevention Zika virus clinical and/or epidemiological criteria.

Thermo Fisher noted that the kit is in a lyophilized format, and the complete testing workflow includes the King Fisher Flex system for automated sample extraction and the QuantStudio Dx Real-Time PCR system.

The US Secretary of Health and Human Services has declared that circumstances exist to justify the emergency use of in vitro diagnostic tests for the detection of Zika virus and/or diagnosis of Zika virus infection. This EUA will terminate when the HHS Secretary's declaration terminates, unless the FDA revokes it sooner.

"As with previous outbreaks, our response is focused on providing standardized testing solutions that simplify the workflow for labs addressing public health threats," Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific, said in a statement. "The FDA's Emergency Use Authorization issued for our Zika test supports that effort."