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(As of March 15, 2017)

FDA EUAs for Zika Tests
(As of March 15, 2017)

by | Mar 31, 2017

Date Issued Test Company Feb. 26, 2016* CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay Zika MAC-ELISA March 17, 2016* CDC Trioplex Real-time RT-PCR Assay Trioplex rRT-PCR April 28, 2016* Zika Virus RNA Qualitative Real-Time RT-PCR Focus Diagnostics, Inc. (subsidiary of Quest Diagnostics) May 13, 2016* RealStar Zika Virus RT-PCR Kit U.S. Altona […]

Date IssuedTest Company
Feb. 26, 2016*CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent AssayZika MAC-ELISA
March 17, 2016*CDC Trioplex Real-time RT-PCR AssayTrioplex rRT-PCR
April 28, 2016*Zika Virus RNA Qualitative Real-Time RT-PCRFocus Diagnostics, Inc. (subsidiary of Quest Diagnostics)
May 13, 2016*RealStar Zika Virus RT-PCR Kit U.S.Altona Diagnostics GmbH
June 17, 2016*Aptima Zika Virus assayHologic, Inc.
July 19, 2016Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR TestViracor-IBT
July 29, 2016*VERSANT® Zika RNA 1.0 Assay (kPCR) KitSiemens Healthcare Diagnostics Inc.
Aug. 4, 2016*xMAP® MultiFLEX™ Zika RNA AssayLuminex Corporation
Aug. 17, 2016ZIKV Detect™ IgM Capture ELISAInBios International, Inc.
Aug. 26, 2016*LightMix® Zika rRT-PCR TestRoche Molecular Systems, Inc.
Sept. 23, 2016Sentosa® SA ZIKV RT-PCR TestVela Diagnostics USA, Inc.
Sept. 28, 2016Zika Virus Detection by RT-PCR TestARUP Laboratories
Nov. 21, 2016*Abbott RealTime ZIKAAbbott Molecular Inc.
Abbott Molecular Inc.Abbott Molecular Inc.ELITechGroup Inc. Molecular Diagnostics

* EUA subsequently expanded after initial issuance

(For more on the development of the market for emergency Zika tests, see NIR, Oct. 28, 2016.)

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