Prodesse, Inc. announced 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 US. 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.” 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.