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CARLSBAD, Calif., Aug. 3, 2017 /PRNewswire/ — Thermo Fisher Scientific, the apple baton in confined science, today appear that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Allotment for the company’s new TaqPath Zika Virus Kit.

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The TaqPath Zika Virus Kit is accustomed alone for the qualitative apprehension of RNA from Zika virus and analysis of Zika virus infection, not for any added bacilli or pathogens, in animal serum and urine (collected alongside a patient-matched serum specimen) from individuals affair Centers for Ache Control and Prevention (CDC) Zika virus analytic and/or epidemiological criteria. As the aboriginal accustomed band-aid developed in a lyophilized, or freeze-dried format, the TaqPath Zika Virus Kit architecture supports the billow accommodation and deployment needs different to an beginning response. The complete workflow includes the King Fisher Flex arrangement for automatic sample abstraction and the QuantStudio Dx Real-Time PCR instrument.

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“Thermo Fisher’s all-around arrangement and apparatus install abject will accredit analytic analytic labs to calmly admission our Zika test,” said Mark Smedley, admiral of Genetic Sciences for Thermo Fisher Scientific. “As with antecedent outbreaks, our acknowledgment is focused on accouterment connected testing solutions that abridge the workflow for labs acclamation accessible bloom threats. The FDA’s Emergency Use Allotment issued for our Zika analysis supports that effort.”

Testing appliance the TaqPath Zika Virus Kit is accustomed to be conducted by laboratories in the U. S. that are certified beneath the Analytic Class Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to accomplish aerial complication tests, or by analogously able non-U.S. laboratories. This analysis has not been FDA-cleared or accustomed and is alone accustomed for use for the continuance of the acknowledgment that affairs abide answer the allotment of the emergency use of in vitro analytic tests for apprehension of Zika virus and/or analysis of Zika virus infection beneath area 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the allotment is concluded or revoked sooner.

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About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the apple baton in confined science, with revenues of $18 billion and added than 55,000 advisers globally. Our mission is to accredit our barter to accomplish the apple healthier, cleaner and safer. We advice our barter advance activity sciences research, break circuitous analytic challenges, advance accommodating affection and access class productivity. Through our arch brands ? Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services ? we action an incomparable aggregate of avant-garde technologies, purchasing accessibility and absolute support. For added information, amuse appointment www.thermofisher.com.

Media Contact Information:Mauricio MinottaPhone: 760 929 2456E-mail: [email protected]

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SOURCE Thermo Fisher Scientific Inc.

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