08.04.17
The U.S. FDA has issued an Emergency Use Authorization for Thermo Fisher Scientific’s new TaqPath Zika Virus Kit for the detection of RNA from Zika virus and diagnosis of Zika virus infection, in individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical and/or epidemiological criteria.
As the first authorized solution developed in a lyophilized format, the TaqPath Zika Virus Kit design supports the surge capacity and deployment needs unique to an outbreak response. The complete workflow includes the King Fisher Flex system for automated sample extraction and the QuantStudio Dx Real-Time PCR instrument.
"Thermo Fisher's global network and instrument install base will enable clinical diagnostic labs to easily access our Zika test," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. "As with previous outbreaks, our response is focused on providing standardized testing solutions that simplify the workflow for labs addressing public health threats. The FDA's Emergency Use Authorization issued for our Zika test supports that effort."
Testing using the TaqPath Zika Virus Kit is authorized to be conducted by laboratories in the U. S. that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. This test has not been FDA-cleared or approved and is only authorized for emergency use.
As the first authorized solution developed in a lyophilized format, the TaqPath Zika Virus Kit design supports the surge capacity and deployment needs unique to an outbreak response. The complete workflow includes the King Fisher Flex system for automated sample extraction and the QuantStudio Dx Real-Time PCR instrument.
"Thermo Fisher's global network and instrument install base will enable clinical diagnostic labs to easily access our Zika test," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. "As with previous outbreaks, our response is focused on providing standardized testing solutions that simplify the workflow for labs addressing public health threats. The FDA's Emergency Use Authorization issued for our Zika test supports that effort."
Testing using the TaqPath Zika Virus Kit is authorized to be conducted by laboratories in the U. S. that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. This test has not been FDA-cleared or approved and is only authorized for emergency use.