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 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.)