14 Apr Prodesse files to market flu diagnostic tool
MILWAUKEE — Prodesse Inc. said it has applied with the U.S. Food and Drug Administration to sell its ProParaflu+ diagnostic product in the United States. It is used as an in vitro diagnostic tool for rapid detection and differentiation of parainfluenza viruses 1, 2 and 3.
Current methods for detection require subjective interpretation from skilled lab technicians and may take several days to determine a result. ProParaflu+ will yield an objective answer within 3 hours, according to the company.
Dr. Karen Harrington, who oversaw clinical trials for Prodesse, noted that this new product, along with the company’s ProFlu+ and Pro hMPV+ share an internal control which allws clinicians to run tests for patients from one nucleic acid extraction. This is Prodesse’s third respiratory and fourth overall real time assay submission.
Flu viruses are a common cause of respiratory infections, especially in children. It 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 Centers for Disease Control, 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.
Prodesse is a biotechnology company focused on developing molecular diagnostic reagents for a variety of infectious disease applications.