17 Sep Prodesse submits Pro hMPV+ assay to FDA for 510(k) clearance
Milwaukee, Wis. – Prodesse, Inc. 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 U.S. 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 three hours.
hMPV was discovered in 2001 by a team of Dutch researchers. It causes acute respiratory illness. Patients infected with hMPV present with symptoms of acute upper and/or lower respiratory tract infections and share the same nonspecific symptoms as many other infectious agents. Coughing, rhinitis, fever, otitis media and dyspnea are the most common symptoms.
The overall incidence of hMPV can vary from year to year and its prevalence has been reported to range from 6.6 to 12% in patients with symptoms of respiratory infection. hMPV is responsible for a significant portion of the 150,000 children hospitalized annually in the United States for bronchiolitis, and it also affects the elderly and the immunocompromised.¨
Prodesse Clinical Trials Coordinator Karen Harrington, PhD commented, “We were quite happy with the performance of our Pro hMPV+ Assay in clinical trials. Because culture is not an adequate `gold standard’ method for detection of hMPV, we used two different PCR assays along with sequencing as the reference method. Pro hMPV+ exhibited very high percent positive and negative agreement with these reference assays.”
Prodesse’s “plus” family of respiratory assays all use a common internal control strategy, so that a single nucleic acid extract may be used in the most appropriate way for respiratory pathogen testing for each particular facility and patient. Pro hMPV+ is the second member of the “plus” family to be submitted for FDA clearance, joining the ProFlu+ Assay which was cleared on January 4, 2008. ProParaflu+, for detection and differentiation of parainfluenza 1, 2 and 3 viruses, is currently in clinical trials. ProAdeno+, for detection of adenovirus, is in development.
Prodesse is a biotechnology company focused on developing molecular diagnostic reagents for a variety of infectious disease applications. The company’s products are designed based on a combination of Prodesse’s patented technologies and other licensed technologies. Prodesse sells FDA 510(k) cleared products worldwide, CE Marked in vitro diagnostic kits outside the U.S. and research use only kits worldwide. The company’s products can be used on multiple nucleic acid extraction and real-time PCR platforms. Prodesse also operates a CLIA certified laboratory for testing services in the Midwest area.