Responding to H7N9 Threat, FDA Issues Emergency Use Authorization for CDC RT-PCR Diagnostic
The U.S. Food and Drug Administration this week issued Emergency Use Authorization for the Centers for Disease Control and Prevention Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 Assay in response to what it called “significant potential for a public health emergency” based on the emergence of the influenza A(H7N9) virus that has led to 23 deaths in China and Taiwan.
Though the assay is intended for research purposes only, the federal agency said that “based on the totality of scientific evidence available to FDA, it is reasonable to believe that the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel-Influenza A/H7 (Eurasian Lineage) Assay may be effective in diagnosing A(H7N9) influenza virus,” and that the known and potential benefits of using it for diagnostic purposes “outweigh the known and potential risks of such product.”
Life Technologies reports that its Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument is the sole platform cleared for use under the CDC protocol created for emergency screenings of patients suspected of harboring H7N9. The company adds that its SuperScript III One-Step qRT-PCR reagent kit “is intended to be used with the CDC's human influenza virus assay to quickly monitor the spread of the pathogen and thwart a potential pandemic.”
The firm also says it is increasing reagent production to meet global need, adding that scientists are currently using its Ion PGM™ Sequencer to characterize the virus in order to determine whether it can be transmitted from human to human.
"We have learned through our past experiences that a strong surveillance program is crucial in times like these," Dan Didier, Life Tech public health director, said in a statement. "We are working continually with our partners around the globe on improving our capabilities, particularly when it comes to developing rapid detection kits."
FDA has issued such authorization for medical devices during past flu emergencies, including the 2009 H1N1 outbreak.