Gen-Probe Inc. (GPRO) announced that the US Food and Drug Administration has granted an EUA or emergency use authorization for its test, the Prodesse ProFlu-ST, to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single sample in individuals who are diagnosed with influenza A by currently available FDA-cleared or authorized devices.
The emergency use authorization authority allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products following a determination and declaration of emergency, provided certain criteria are met. In the case of the ProFlu-ST, the FDA has only authorized its use for the duration of the emergency, which is currently set to expire on April 26, 2010, unless it is terminated, revoked sooner or renewed.
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