NEWS

FDA Watch: Agency Okays Marketing of Zika Test for First Time

Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It authorized marketing of a diagnostic test for the Zika virus—specifically, Seattle-based InBios’ ZIKV Detect 2.0 IgM Capture Elisa for detecting immunoglobulin (IgM) antibodies in human blood, an assay previously cleared for emergency use only. Here’s the lowdown on the approval and its significance.

The Context: About Zika

The Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. Although many people with Zika virus infection experience no symptoms, the virus can pose potentially serious risks to the public health. Links between Zika virus infection and neurological complications (i.e., Guillain-Barré Syndrome), as well as microcephaly (abnormal smallness of the head) and other poor outcomes associated with Zika virus infection during pregnancy, have increased the importance of having diagnostic tests available for Zika virus.

In 2016, the Centers for Disease Control and Prevention (CDC) announced that limited local mosquito-borne Zika virus transmission had been reported in the continental United States. In 2018 and 2019, no such local transmission was reported.

About the Test + Authorization

The ZIKV Detect 2.0 IgM Capture ELISA is designed to identify proteins (antibodies) produced by the body’s immune system when it tests for Zika virus infection in the blood. IgM antibodies indicate an early immune response. The test is for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or who meet the CDC’s Zika virus epidemiological criteria, such as a history of residence in or travel to a geographic region with active Zika transmission at the time of travel. The FDA authorization doesn’t cover testing of blood or plasma donors.

Results of ZIKV Detect 2.0 IgM Capture ELISA are intended for use in conjunction with clinical observations, patient history, epidemiological information and other laboratory evidence to make patient management decisions. The assay also differentiates Zika IgM from those infected with other flaviviruses (such as dengue or West Nile virus) which cross-react with Zika antibodies

Why Now + Why InBios?

Moving beyond EUA to marketing authorization is a seminal shift in FDA policy. FDA Acting Commissioner Ned Sharpless, M.D., sheds light on the agency’s thinking. “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities,” Sharpless explained.

Comfort with the effectiveness of the InBios Zika assay enabled the agency to take the next step. According to InBios, the assay was evaluated via testing 807 unique specimens—353 from test subjects at sites where Zika is endemic and 256 subjects at non-endemic sites. In samples from patients collected seven days or later after the onset of symptoms, the InBios Zika kit correctly identified over 90% of patients confirmed positive for Zika IgM and over 96% of patients confirmed negative.

The authorization doesn’t impact the availability of the 14 other Zika nucleic acid diagnostics available under EUAs.

Zika Tests with EUA Clearance from FDA

Test Company
CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay Zika MAC-ELISA
CDC Trioplex Real-time RT-PCR Assay Trioplex rRT-PCR
Zika Virus RNA Qualitative Real-Time RT-PCR Focus Diagnostics, Inc. (subsidiary of Quest Diagnostics)
RealStar Zika Virus RT-PCR Kit U.S. Altona Diagnostics GmbH
Aptima Zika Virus assay Hologic, Inc.
Viracor-IBT Laboratories, Inc.’s Zika Virus Real-time RT-PCR Test Viracor-IBT
VERSANT® Zika RNA 1.0 Assay (kPCR) Kit Siemens Healthcare Diagnostics Inc.
xMAP® MultiFLEX™ Zika RNA Assay Luminex Corporation
ZIKV Detect™ IgM Capture ELISA InBios International, Inc.
LightMix® Zika rRT-PCR Test Roche Molecular Systems, Inc.
Sentosa® SA ZIKV RT-PCR Test Vela Diagnostics USA, Inc.
Zika Virus Detection by RT-PCR Test ARUP Laboratories
Abbott RealTime ZIKA Abbott Molecular Inc.
Abbott Molecular Inc. ELITechGroup Inc. Molecular Diagnostics
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