Emerging Markets: The Rapid Rise of Commercial Zika Diagnostics

The rapid emergence of the Zika threat is creating a new in vitro diagnostics market that did not exist a year ago. Here’s a quick overview of the Zika market, how it developed and where it stands today.

Incubation of the Market
Zika is a mosquito-borne virus first discovered in Uganda in 1947. The first major Zika outbreak occurred in the Pacific in 2007; by 2016, local infections were occurring in over 20 countries across the Americas, according to World Health Organization estimates. The primary means of diagnosing Zika is specialized laboratory blood testing to detect the two breeds of mosquitoes that spread the virus. As late as May 2016, those tests were performed almost entirely by the CDC and a handful of state and public health departments. But as the threat crept closer to American shores, commercial labs in the US stepped up efforts to develop a diagnostic test for Zika.

The FDA Stimulus
The Food and Drug Administration (FDA) served as the engine of growth by using its authority to approve experimental tests for limited emergency uses. The FDA began issuing Emergency Use Authorizations (EUAs) in February 2016 for two forms of Zika diagnostic tests:

  • Molecular/Nucleic Acid Amplification Tests; and
  • Zika Virus Antibody/Serological Tests.

The first EUAs were for antibody tests detecting the Zika mosquito breeds performed by the CDC and state health departments. Those same mosquito breeds also transmit dengue and yellow fever. Because there was, at the time, no test to distinguish Zika from dengue, the serological tests were of limited diagnostic use. However, Nirmidas Biotech, a startup Palo Alto firm founded by Stanford University has reportedly developed a serological test for rapidly distinguishing Zika virus infection from Dengue virus infection in both acute and convalescent patients, according to a March 6, 2017 article published in Nature Medicine.

Commercial Breakthroughs
In April 26, a breakthrough occurred when the FDA approved its first test developed by a commercial lab molecular test for Zika by issuing an EUA for Zika Virus RNA Qualitative Real-Time RT-PCR test, a molecular test from Quest Diagnostics subsidiary Focus Diagnostics. EUAs to other commercial labs followed—Altona, Hologic, Siemens, Luminex, Roche, Abbott, among others—in quick succession.

The most recent commercial breakthrough took place in February when Abbott Laboratories’ RealTime Zika assay became the first whole blood molecular test to receive FDA approval. The approval is an expansion of the EUA that the FDA issued in November 2016 approving RealTime for use on human serum, EDTA plasma and urine samples to whole blood samples.

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.)


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