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Prodesse Gets FDA OK for Parainfluenza Virus Assay

NEW YORK (GenomeWeb News) – Prodesse said after the close of the market Tuesday that the US Food and Drug Administration has cleared the firm's ProParaflu+ assay for detecting and differentiating parainfluenza 1, 2, and 3 viruses.

The assay uses real-time RT-PCR to identify the parainfluenza 1, 2, and 3 viruses from nasal swabs. It joins a line of molecular assays for respiratory viruses already sold in the US by Prodesse, which is now a subsidiary of Gen-Probe. The other tests are the ProFlu+ to detect and differentiate influenza A virus, influenza B virus, and respiratory syncytial virus, and the Pro hMPV+ to detect human metapneumovirus.

In addition, Prodesse makes the ProFlu-ST, 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.

"Although parainfluenza virus infections aren't serious in most people, they can cause dangerous complications in young children, the elderly and other patient groups," Eric Tardif, Gen-Probe's senior vice president of corporate strategy and general manager of Prodesse, said in a statement. "We believe our assay will be an important tool to help physicians accurately identify these infections, especially when the prevalence of other viruses is high."

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