Gen-Probe Incorporated has announced that Prodesse's ProFAST+ assay has become the first molecular diagnostic test to receive clearance from the US Food and Drug Administration (FDA).
The device allows physicians to simultaneously detect and differentiate among three common influenza A virus subtype – seasonal A/H1, seasonal A/H3 and 2009 H1N1.
The ProFAST+ assay is a multiplex, real-time polymerase chain reaction in vitro diagnostic test that detects influenza A from nasopharyngeal swabs.
