FDA EUAs for Zika Tests
(As of March 15, 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 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 Diagnostics GmbH |
June 17, 2016* | Aptima Zika Virus assay | Hologic, Inc. |
July 19, 2016 | Viracor-IBT Laboratories, Inc.'s Zika Virus Real-time RT-PCR Test | Viracor-IBT |
July 29, 2016* | VERSANT® Zika RNA 1.0 Assay (kPCR) Kit | Siemens Healthcare Diagnostics Inc. |
Aug. 4, 2016* | xMAP® MultiFLEX™ Zika RNA Assay | Luminex Corporation |
Aug. 17, 2016 | ZIKV Detect™ IgM Capture ELISA | InBios International, Inc. |
Aug. 26, 2016* | LightMix® Zika rRT-PCR Test | Roche Molecular Systems, Inc. |
Sept. 23, 2016 | Sentosa® SA ZIKV RT-PCR Test | Vela Diagnostics USA, Inc. |
Sept. 28, 2016 | Zika Virus Detection by RT-PCR Test | ARUP Laboratories |
Nov. 21, 2016* | Abbott RealTime ZIKA | Abbott 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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