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.

Go deeper with GlobalData

Go deeper with GlobalData

The gold standard of business intelligence.

Find out more

Discover B2B Marketing That Performs

Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.

Find out more

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.

"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."

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.

GlobalData Strategic Intelligence

US Tariffs are shifting - will you react or anticipate?

Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.

By GlobalData

"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.

Medical Device Network Excellence Awards - Nominations Closed

Nominations are now closed for the Medical Device Network Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact

Excellence in Action
Awarded for Innovation in Remote Hearing Diagnostics , hearX’s Self Test Kit (STK) delivers clinically validated audiometry via smart devices, enabling remote, scalable hearing assessments in homes, clinics and retail. Learn how hearX is redefining hearing care delivery and reducing costs for providers globally.

Discover the Impact