FDA Issues Emergency Use Authorization for Thermo Fisher Scientific's Zika Virus Assay

Published : Friday, August 4, 2017, 10:58 am
ACROFAN=Yong-Man Kwon | | SNS
Thermo Fisher Scientific, 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.

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.

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