Gen-Probe Gets FDA Emergency Use Authorization for Flu Test | GenomeWeb

NEW YORK (GenomeWeb News) – Gen-Probe today said that the US Food and Drug Administration has granted an Emergency Use Authorization for the firm's Prodesse ProFlu-ST assay for use in CLIA high-complexity labs for diagnosis of 2009 H1N1 influenza virus infection.

The FDA granted the EUA for use of the test "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."

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