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FDA Approves CDC s RT-PCR Test for Avian Flu

NEW YORK, Feb. 3 (GenomeWeb News) - The US Food and Drug Administration said today it has approved a CDC-developed diagnostic for H5 strains of avian influenza in human patients.


The Influenza A/H5 Virus real-time RT-PCR primer and probe set provides preliminary results on suspected samples within four hours of testing, said the FDA in a statement.


"Using flexible regulatory authorities, FDA was able to prioritize this expedited approval based on the clear critical need," said acting FDA commissioner Andrew von Eschenbach.


Additional information can be found here.

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