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FDA Clears Prodesse RT-PCR Flu Test

NEW YORK (GenomeWeb News) – Prodesse has received US Food and Drug Administration clearance to market its real-time PCR-based flu test, the company said yesterday.
The firm’s 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.
Prodesse said other tests are on the way, including one for human metapneumovirus that is in clinical trials now and another to differentiate parainfluenza viruses that is soon to begin clinical trials.
Clearance of the Prodesse flu assay comes in the same week that the FDA cleared for marketing a respiratory viral panel from Luminex.
Luminex’s xTag Respiratory Viral Panel is based on the firm’s xMAP bead technology and targets 12 viruses that account for over 85 percent of respiratory viral infections, including various influenza strains.
Prodesse claims that its real-time PCR-based test would provide advantages, such as reduced hands-on time, elimination of amplicon contamination, and relatively low equipment costs, over other molecular diagnostic technologies including microbeads and microarrays.

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