MILWAUKEE, WI (June 4, 2008) – Prodesse, Inc. announced today that clinical trials of its new ProParaflu+ test have begun. ProParaflu+ is a multiplex real-time PCR assay for the rapid detection and differentiation of parainfluenza viruses 1, 2 and 3. This is Prodesse’s third respiratory assay and its fourth product to undergo clinical trials for FDA clearance. The company’s flagship ProFlu+™ product first received FDA 510(k) clearance in January and its Pro hMPV+™ product has completed clinical trials with a planned submission to the FDA in late summer. These three respiratory products share a common internal control allowing clinicians to easily run the most appropriate series of tests for their patients from just a single nucleic acid extraction.
Prodesse CEO Tom Shannon commented, “Of the one dozen clinical trial sites we have administered during the past six months, the four ProParaflu+ sites represent our broadest geographical mix yet. The geographical diversity of the sites coupled with the lengthening of the trials, in comparison to the others we have conducted, should allow us to capture the necessary number of positive samples needed for the clearance of all three parainfluenza subtypes. Diagnostic Laboratory Services of Honolulu, Hawaii and Nationwide Children’s Hospital in Columbus, Ohio are again participating in this trial while we have also expanded to some new sites by adding the Medical College of Wisconsin in Milwaukee and TriCore
Reference Laboratories in Albuquerque. The 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+ can yield an objective answer in as little as 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.
Press Contact:
Andy Shrago, Chief Marketing Officer
Prodesse, Inc.
Phone: (262) 446-0700
Email: ashrago@prodesse.com
