Key Developments For Gen Probe Inc
Gen Probe Inc (GPRO.O) (Nasdaq)
Gen-Probe Incorporated Subsidiary's ProParaflu Assay Cleared For US Marketing By FDA
Gen-Probe Incorporated announced that the US Food and Drug Administration (FDA) has cleared for marketing Prodesse's ProParaflu assay, a molecular test that detects and differentiates parainfluenza 1, 2 and 3 viruses, which cause lower respiratory tract infections. Prodesse is a wholly-owned subsidiary of the Company.
Gen-Probe Incorporated Receives European CE Mark
Gen-Probe Incorporated announced that Prodesse's ProFlu-ST assay, a molecular test that detects the 2009 H1N1 influenza virus and differentiates it from two common seasonal strains, has received its CE (Conformite Europeenne) Mark, enabling it to be commercialized in the European Union.
Gen-Probe Incorporated Narrows FY 2009 Revenue Guidance; Narrows FY 2009 EPS To A Range Above Analysts' Estimates
Gen-Probe Incorporated updated its fiscal 2009 guidance and now expects total non-GAAP revenue to be in the range of $493-$500 million compared to previous guidance of $490-$503 million, GAAP revenue to be in the range of $493-$500 million compared to previous guidance of $490-$503 million, non-GAAP earnings per share (EPS) of $1.90 to $1.93 compared to previous guidance of $1.85 to $1.95 and GAAP EPS of $1.77 to $1.79 compared to previous guidance of $1.73 to $1.85. According to Reuters Estimates, analysts were expecting the Company to report revenue of $493 million and EPS of $1.88 for fiscal 2009.
FDA Grants Emergency Use Authorization Of Gen-Probe Incorporate's ProFlu-ST
Gen-Probe Incorporated announced that US Food and Drug Administration (FDA) has granted an EUA (emergency use authorization) for its test, the Prodesse ProFlu-ST, 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. 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.
Gen-Probe Incorporated Completes Acquisition of Prodesse, Inc.
Gen-Probe Incorporated announced that the Company has completed its acquisition of Prodesse, Inc., for approximately $60 million in cash.
