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Prodesse Gets FDA OK for H1N1 Claims for Assay

This article contains a clarification in the first graf regarding the claims for the ProFlu+ assay.

NEW YORK (GenomeWeb News) – Prodesse today said that the US Food and Drug Administration has cleared additional claims for the firm's ProFlu+ assay, which says that it correctly identifies as Influenza A positive specimens containing novel 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.

"Prodesse's recently completed reactivity testing confirms that our ProFlu+ test can be an important tool for health care professionals in the diagnoses of their patients, particularly during the Influenza A outbreak," Tom Shannon, president and CEO of Prodesse, said in a statement.

The ProFlu+ assay was initially cleared by FDA in January 2008 for the detection and discrimination of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus.

Last month, FDA issued an Emergency Use Authorization for Focus Diagnostics' molecular assay for detecting the 2009 H1N1 flu virus.