MILWAUKEE, WI (January 4, 2008) – Prodesse, Inc., the leader in multiplex real-time PCR for infectious disease, announced today it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ProFlu+™ Assay. The clearance came in about two months from submission. ProFlu+ is a molecular diagnostic assay that, from a single specimen, simultaneously detects and differentiates influenza A virus, influenza B virus and respiratory syncytial virus (RSV). Not only is it the first real-time molecular diagnostic test for respiratory viruses to receive FDA clearance, but also it is the first cleared real time molecular infectious disease test to detect as many as three organisms simultaneously.
