24 Aug Prodesse Gets FDA OK for H1N1 Claims for Assay
Prodesse today said that the US Food and Drug Administration has cleared additional claims for the firm’s ProFlu+ assay, which says that the assay can detect the 2009 H1N1 influenza virus.
The Milwaukee, Wis.-based firm said in a statement that reactivity testing completed by the firm confirmed that the ProFlu+ test correctly identifies the Influenza A positive specimens containing novel 2009 H1N1 influenza virus. It noted that the testing was conducted on cultures of clinical isolates confirmed as 2009 H1N1 Influenza Virus using the CDC’s real-time RT-PCR assay.
Prodesse also noted that its can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.
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