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FDA Issues Emergency Use Authorization for PCR-based A(H7N9) Influenza Virus Assay

NEW YORK (GenomeWeb News) – The US Food and Drug Administration this week issued an emergency use authorization, or EUA, for a Centers for Disease Control and Prevention assay for the detection of influenza A virus subtype H7N9.

On Monday, FDA issued the EUA for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay for the "presumptive detection" of influenza A(H7N9) in conjunction with the FDA-cleared CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel in real-time RT-PCR (rRT-PCR) assays. The assay is to be used for patients who show signs and symptoms of respiratory infection, FDA said.

The assay will be distributed by CDC to public health and other qualified laboratories only and is to run on the FDA-cleared Applied Biosystems 7500 Fast Dx Real-Time PCR platform.

FDA issued the EUA after the Secretary of the Department of Health and Human Services determined a "significant potential" for a public health emergency involving US citizens living abroad. Because of that threat, the HHS Secretary further determined that it was necessary to authorize the use of in vitro diagnostics to detect the A(H7N9) influenza virus, FDA Commissioner Margaret Hamburg said in her letter of authorization issuing the EUA.

The A (H7N9) influenza virus is a serotype of the avian influenza virus, or bird flu virus, which so far has been reported exclusively in Asia, predominantly in China. The first cases of human infection were confirmed in late March, and since then, more than 100 cases and more than 20 deaths have been reported.

In her authorization letter, Hamburg noted three reasons for issuing the EUA. The A(H7N9) influenza virus can be serious, even life-threatening, to humans, she said. Also, based on the evidence available to FDA, the CDC assay appears to be effective in diagnosing the A(H7N9) virus. Lastly, there is no other "adequate, approved, and available" alternative to the assay for emergency use, Hamburg said.