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Gen-Probe Gets FDA Emergency Use Authorization for Flu Test

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."

The test uses real-time PCR to detect the virus and return results in as little as three hours. The ProFlu-ST was developed by Prodesse, which recently was acquired by Gen-Probe for at least $60 million.

"This test complements nicely our FDA cleared ProFlu+ Assay, which from a single sample, detects and discriminates influenza A virus, influenza B virus and RSV," Andy Shrago, head of marketing for Prodesse products, said in a statement.

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