FDA Issues Emergency Use Authorization for Thermo Fisher Scientific's Zika Virus Assay
Published: Aug 04, 2017
CARLSBAD, Calif., Aug. 3, 2017 /PRNewswire/ -- Thermo Fisher Scientific, the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization for the company's new TaqPath Zika Virus Kit.
The TaqPath Zika Virus Kit is authorized only for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection, not for any other viruses or pathogens, in human serum and urine (collected alongside a patient-matched serum specimen) from 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, or freeze-dried 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 use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $18 billion and more than 55,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
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SOURCE Thermo Fisher Scientific Inc.