MILWAUKEE, WI (September 17, 2008) – Prodesse, Inc. announced today it has filed a submission with the FDA for 510(k) clearance to market its Pro hMPV+ Assay as an in vitro diagnostic product in the United States. Clinical trials were conducted at four clinical laboratories in the US. The clinical trial sites reported that Pro hMPV+ was easy-to-use and that it appeared to rapidly and accurately detect human metapneumovirus (hMPV). Non-molecular methods of detecting this virus are generally considered sub-optimal for clinical purposes. Because hMPV is difficult to culture, this method is relatively insensitive and takes days to weeks. Other methods, such as immunoassays, also lack sensitivity. The real-time PCR technology used in Pro hMPV+ makes the detection process far more effective than other methods, yielding answers in as little as 3 hours.
