Gen-Probe (GPRO) Gets U.S. FDA Clearance for Marketing Prodesse's ProParaflu+ Assay
Gen-Probe Incorporated (NASDAQ: GPRO) announced today 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 Gen-Probe, a global leader in molecular diagnostics.
The ProParaflu+ assay uses real-time RT-PCR (polymerase chain reaction) to identify the parainfluenza 1, 2 and 3 viruses from nasal swabs. The assay uses the same internal control as Prodesse's other tests for respiratory infectious diseases, so a single nucleic acid extract can be tested with any combination of these products. Prodesse markets these respiratory tests in the United States:
- ProFlu+, which received FDA clearance in 2008 to detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus (RSV).
- Pro hMPV+(TM), which received FDA clearance in 2008 to detect human metapneumovirus.
- ProFlu-ST(TM), which is available under an FDA emergency use authorization (EUA) 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.
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