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.
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
