Gen-Probe receives FDA emergency use authorization for its Prodesse ProFlu-ST test

Oct 29 2009

Gen-Probe Incorporated (Nasdaq: GPRO) today announced that the US Food and Drug Administration (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.

Andy Shrago, head of marketing for Prodesse products, said, "Many experts are expecting continued high levels of 2009 H1N1 infections through this next flu season, along with a return of either or both of the seasonal flu strains, so we believe that with this EUA, ProFlu-ST can help provide top-notch care. This test complements nicely our FDA cleared ProFlu+(TM) Assay, which from a single sample, detects and discriminates influenza A virus, influenza B virus and RSV."