03 Sep Prodesse releases flu assay in Europe
Milwaukee, Wis. – Prodesse, Inc. announced today the commercial release of its CE Marked ProParaflu+ Assay for European and other customers outside the U.S. It is also now available in the US as a Research Use Only product for non-clinical use.
ProParaflu+ rapidly and accurately detects and differentiates 3 strains of parainfluenza virus. The two most common currently used methods of detection have serious shortcomings. DFA (direct fluorescent antibody) lacks sensitivity and requires a subjective determination. Culturing for respiratory viruses is a slow process – from a few days to 2 weeks – and, while more sensitive than DFA, respiratory viral culturing is generally less sensitive than well-designed molecular methods. The real-time PCR technology used in ProParaflu+ makes the detection process far more effective than other methods, yielding answers in as little as 3-4 hours.
Parainfluenza 1 virus is the leading cause of croup in children, while parainfluenza 3 virus is more commonly associated with bronchiolitis and pneumonia. The highest rates of serious illness from the parainfluenza viruses occur among children. Parainfluenza is second only to respiratory syncytial virus (detected by ProFlu+) as a cause for hospitalization of pediatric patients, causing perhaps 100,000 pediatric hospitalizations annually. The parainfluenza viruses have also been implicated in pneumonia and other respiratory illnesses in adults; the elderly and immunocompromised being particularly at risk.
Prodesse Chief Marketing Officer Andy Shrago commented, “We have been very pleased with the performance of our ProParaflu+ Assay, and our clinical trial sites have all reported the product is very user-friendly. As expected, the clinical trials sites have detected a substantial number of parainfluenza 3s in the summer, therefore this assay will be highly useful year-round. We expect to complete our US clinical trials in early 2009 and anticipate submission for FDA 510(k) clearance next spring.”
ProParaflu+ joins the FDA-cleared ProFlu+ and FDA-clearance-pending Pro hMPV+ as the third member of our “plus” family, a series of products using the same internal control 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. The fourth member, ProAdeno+, for adenovirus, is currently 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 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.