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U.S. Department of Health and Human Services


BARDA-supported Zika Virus Test Receives FDA Clearance; Ready for Clinical Laboratory Use

Author: Rodney L. Wallace, Director, Detection, Diagnostics, and Devices Infrastructure Division, HHS/ASPR Biomedical Advanced Research and Development Authority
Published Date: 6/6/2019 10:36:00 AM
Category: Innovations; Medical Countermeasures; Hospital Preparedness;

The first commercially available Zika virus diagnostic, a product BARDA supported through its advanced research and development program, received authorization for marketing from the U.S. Food and Drug Administration (FDA) on May 23. The test provides results from a blood sample in about four hours. Called the ZIKV Detect 2.0 IgM Capture ELISA, the test exemplifies the progress that is possible with public-private partnerships.

Zika virus emerged as public health threat in 2015, and by 2016 cases of Zika virus were reported in every U.S. state except Alaska. However, the U.S. did not have an approved high-capacity, rapid Zika diagnostic test to inform patient care, a need that was particularly critical for pregnant women.

Early in the outbreak, BARDA prioritized support for the development of Zika-specific serological (IgM) assays, which test blood for antibodies produced by the body’s immune system. BARDA also worked with partners in industry to spur the development of these tests. InBios International, Inc. was one of the companies that answered the call to help diagnose Zika virus infection more effectively.

BARDA funded work by InBios with a $5.1 million contract. The funding supported refinement of the ZIKV IgM Capture ELISA design and performance, manufacturing preparations, and the clinical studies necessary for the FDA de novo premarket pathway, a pathway used when there is no existing classification or predicate device on the market.

The diagnostic test is designed to detect a Zika virus-specific Immunoglobulin M, or IgM, antibodies produced by the body’s immune response to the virus. The new test can detect an early immune response at about one week from exposure.

The initial InBios test was made available under FDA Emergency Use Authorization in August 2016 and provided increased capacity for Zika testing nationwide. The FDA-cleared ZIKV Detect 2.0 IgM Capture ELISA differentiates Zika IgM antibodies from those produced by other flaviviruses, such as dengue or West Nile virus. This improvement in specificity reduces the challenges of diagnosing recent Zika infection in people who previously have been infected with another flavivirus.

In just over three years, BARDA has worked with its public-private partners to make great strides in building a portfolio of medical countermeasures to address the threat caused by Zika. This portfolio includes four other Zika diagnostic tests to determine individual infections, including one that potentially can be administered in a doctor’s office and yield results in minutes. BARDA also is working with private sector partners to support the development of Zika vaccines, and pathogen reduction technologies. Two high-throughput tests were supported by BARDA and now are approved and in use to screen the U.S. blood supply.

FDA’s authorization of this latest diagnostic marks another important milestone in the fight against Zika and demonstrates the success of public-private partnerships in the fight against emerging infectious diseases.


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