Gen-Probe (GPRO) Gets Emergency Use Authorizaton From U.S. FDA for Prodesse ProFlu-ST Test
Gen-Probe Incorporated (NASDAQ: GPRO) today announced that the US FDA has granted an EUA (emergency use authorization) for its test, the Prodesse ProFlu-ST(TM), 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.
With the EUA, ProFlu-ST becomes the first commercially available RT-PCR (polymerase chain reaction) test that can detect and identify the 2009 H1N1 influenza virus, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, for the duration of the declared public health emergency. Because the three influenza A subtypes currently have different susceptibilities to influenza antiviral drugs, this capability is important for clinicians and patients during this flu season.
The real-time PCR technology used in ProFlu-ST is simple to use and easily integrates into a lab's existing workflow. The product has been optimized for use with automated extraction technology that minimizes technician hands-on time. This ease-of-use enables labs to quickly validate the product for use. Test results can be obtained in as little as three hours using the assay - a significant improvement over culture-based methods that can take up to weeks to produce a result. During a public health emergency, this speed to result and the exceptional sensitivity of molecular testing are extremely important from an infection control perspective.
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