NEW YORK (GenomeWeb News) – Molecular diagnostics company Prodesse said today that the US Food and Drug Administration has authorized two changes to the packaging on the company’s influenza assay.
The FDA, which cleared the company’s ProFlu+ at the beginning of 2008, has accepted using the bioMérieux NucliSENS easyMAG automated nucleic acid extraction system with the ProFlu+ test, the company said.
The FDA also has removed a recommendation that negative results for influenza A and influenza B should be confirmed by culture. That makes this test the first molecular test for respiratory viruses that the FDA has decided does not require a backup, the Milwaukee, Wis.-based company said.
Prodesse CEO Tom Shannon said that “only a test that shows exceptional performance compared to culture can have this recommendation removed.”
The ProFlu Assay is designed to simultaneously detect and differentiate influenza A and B viruses and respiratory syncytial virus, and provides results in around three hours.