Emergency Use Authorization Issued for New H7N9 In Vitro Diagnostic Product

On Feb. 14, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Lyra™ Influenza A Subtype H7N9 Assay manufactured by Quidel Corporation for the presumptive detection of novel influenza A (H7N9) virus. This In Vitro Diagnostic (IVD) product is for use in Clinical Laboratory Improvement Amendments High Complexity Laboratories for patients with signs and symptoms of respiratory infection who have positive specimens for influenza A viral RNA that were determined to be un-subtypable.

In April 2013, prior to this most recent EUA, Health and Human Services Secretary Kathleen Sebelius determined that H7N9 poses a significant potential for a public health emergency that has a significant potential to affect the health and security of United States citizens living abroad. These circumstances justified the authorization of emergency use of IVDs for H7N9 detection. On April 22, 2013, the FDA issued an EUA for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay.

More information and the final EUA documents are available on the FDA’s website.

About Lisa Brown

Lisa Brown serves as a Senior Program Analyst for Environmental Health, Pandemic Response, and Catastrophic Preparedness at NACCHO. Her work includes climate change preparedness, medical countermeasure planning and implementation efforts, and exploring the legal issues surrounding radiation preparedness.Twitter: @LisaBrownMPH

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