For Immediate Release
Prodesse Releases CE Marked Multiplex PCR Assay in
Europe for Detection of Parainfluenza Virus
ProParaflu+™ joins ProFlu+™ and Pro hMPV+™ in Prodesse’s series of real-time
molecular assays for respiratory virus detectionFor Immediate Release
MILWAUKEE, WI (June 17, 2008) – Prodesse, Inc. announced today the commercial release of its CE Marked Pro hMPV+™ Assay for European and other customers outside the US. It is also now available in the US as a Research Use Only product for non-clinical use. Pro hMPV+ represents Prodesse’s second generation hMPV product with all necessary enzymes now included. Pro hMPV+ rapidly and accurately detects human metapneumovirus (hMPV). Non-molecular methods of detecting this virus are generally considered sub-optimal for clinical purposes. Because hMPV is difficult to culture, this method is relatively insensitive and takes days to weeks. Other methods, such as immunoassays, also lack sensitivity. The real-time PCR technology used in Pro hMPV+ makes the detection process far more effective than other methods, yielding answers in as little as 3 hours.
hMPV was discovered recently by a team of Dutch researchers, and various studies have implicated it in 5-20% of pediatric respiratory infections. As with other respiratory viruses, it also affects the elderly and the immunocompromised. ViroNovative of Rotterdam, The Netherlands owns wide-reaching patents pending for the detection of hMPV.
Prodesse Chief Marketing Officer Andy Shrago commented, “We have been very pleased with the performance of our Pro hMPV+ Assay in clinical trials, and our trial sites have all reported the product is very user-friendly. Rather than culture, we used two different PCR assays along with sequencing as the reference method. Even with this very aggressive comparator, Pro hMPV+ still achieved excellent sensitivity and specificity. Our test is the only molecular test for clinical use that has been appropriately licensed. We anticipate submission for FDA 510(k) clearance this summer.”
Pro hMPV+ joins the already FDA cleared ProFlu+ as the second 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. ProParaflu+™ is currently in clinical trials, and ProAdeno+™ is currently in development.
MILWAUKEE, WI (September 3, 2008) – Prodesse, Inc. announced today the commercial release of its CE Marked ProParaflu+™ Assay for European and other customers outside the US. 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.
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