Thermo Fisher’s Zika virus assay secures FDA’s emergency use authorization
Thermo Fisher Scientific has secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Zika virus assay.
The TaqPath Zika Virus Kit is currently authorised for diagnosis of infection by Zika virus and the qualitative detection of RNA from the virus in human serum and urine samples.
The assay can be applied to samples that are taken from people meeting Centres for Disease Control and Prevention (CDC) Zika virus clinical and/or epidemiological criteria.
TaqPath is available in a freeze-dried format and can support the surge capacity and deployment needs during an outbreak, while delivering results within two hours.
While an automated sample extraction can be performed with the King Fisher Flex system, the assay can be used alongside the QuantStudio Dx Real-Time PCR instrument.
Thermo Fisher Scientific genetic sciences president Mark Smedley said: "Thermo Fisher's global network and instrument install base will enable clinical diagnostic labs to easily access our Zika test.
"As with previous outbreaks, our response is focused on providing standardised testing solutions that simplify the workflow for labs addressing public health threats. The FDA's EUA issued for our Zika test supports that effort."
The TaqPath Zika Virus Kit is not authorised for identification or detection of any other viruses or pathogens. It can be used by the laboratories that are certified to carry out high-complexity tests.
With revenues of $18bn, Thermo Fisher Scientific provides life sciences research, diagnostic and laboratory productivity services.
Image: Thermo Fisher's new TaqPath Zika Virus Kit is designed in a freeze-dried format. Photo: courtesy of Thermo Fisher Scientific Inc.