MILWAUKEE, WI (April 14, 2009) – Prodesse, Inc. announced today that it has filed a submission with the US Food and Drug Administration for 510(k) clearance to market its ProParaflu+ assay as an in vitro diagnostic product in the United States. ProParaflu+ is a real time RT-PCR assay for the rapid detection and differentiation of parainfluenza viruses 1, 2 and 3. This is Prodesse’s third respiratory and fourth overall real time assay submission.
Dr. Karen Harrington who oversaw the clinical trials for the company commented, “Our sites were excited about the performance of this unique molecular product. We expected parainfluenza 3 infections to be strong in the summer, but were surprised to see continued prevalence into the winter. Along with ProFlu+™ and Pro hMPV+™ these three respiratory products with their seven detections share an internal control allowing clinicians to easily run the most appropriate series of tests for their patients from just a single nucleic acid extraction.”
Human parainfluenza viruses are a common cause of respiratory infections, especially in children. In fact, parainfluenza is second only to respiratory syncytial virus as a cause of hospitalization of pediatric patients. Parainfluenza 1 virus is the leading cause of croup in children. Parainfluenza 3 is often associated with bronchiolitis and pneumonia. According to the CDC, parainfluenza viruses are the second most common cause of lower respiratory tract infections in young children and can cause repeated infections throughout life. In addition, the elderly and the immunocompromised are also at higher risk for lower respiratory tract infections from parainfluenza viruses. Current methods for detection require subjective interpretation from highly-skilled laboratorians and may take several days to determine a result. ProParaflu+ will yield an objective answer within 3 hours.
About Prodesse
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 US 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. For more information about Prodesse and its products, call 888-589-6974 or go to www.prodesse.com.
