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October 29, 2009

FDA Grants Emergency Use Authorization to Gen-Probe's PCR Test for the H1N1 Flu

  • Gen-Probe has been granted an EUA (emergency use authorization) for the Prodesse ProFlu-ST™ to be used in CLIA high-complexity laboratories for detection of the 2009 H1N1 influenza virus. The test is aided by an algorithm that relies on seasonal influenza A/H1 and A/H3 virus results from a single sample in individuals who are diagnosed with influenza A by currently available devices.

    Under the EUA, the agency has authorized the use of ProFlu-ST only during the H1N1 flu emergency, which is currently set to expire on April 26, 2010. The test becomes the first commercially available RT-PCR diagnostic that can detect and identify the 2009 H1N1 influenza virus, according to Gen-Probe. Test results are reportedly obtained in three hours using the assay; culture-based methods can take up to weeks to produce a result, the firm adds.

    “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 (respiratory syncytial virus),” notes Andy Shrago, head of marketing for Prodesse products.

    Both the ProFlu-ST and ProFlu+ tests were obtained through the acquisition of Prodesse, completed on October 21. Prodesse had three FDA 510(k)-cleared products and two additional CE-marked products in Europe.

    Prodesse's ProFlu+ test was sanctioned by the FDA in January 2008 for the detection and discrimination of influenza A virus, influenza B virus, and RSV. Prodesse also sold assays for the clinical diagnosis of Clostridium difficile and human metapneumovirus in the U.S.


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