The Pro hMPV+ Assay uses real-time PCR (polymerase chain reaction) technology; it is simple to use and easily integrates into existing lab workflow. Real-time technology offers clear advantages over other molecular diagnostic techniques such as microbeads and microarrays because little hands-on time is required, risk of amplicon contamination is eliminated, equipment cost is relatively low and inducement concerns (resulting from running a large panel of tests, some of which may not be medically-indicated) are minimized. Test results from the Pro hMPV+ Assay are available in about 3 hours.
Because hMPV does not culture well and there is no accepted ‘gold standard’, the accuracy of the Pro hMPV+ Assay was confirmed in a multi-site clinical study comparing results to two molecular reference assays using different gene targets where a positive by either of the two reference assays was considered a true positive. Using this stringent methodology, Pro hMPV+ achieved 94% positive agreement and 99% negative agreement. Pro hMPV+ joins ProFlu+ in the lineup of cleared Prodesse respiratory assays. A third assay, ProParaflu+™ for detection of parainfluenza viruses, is currently in clinical trials, and ProAdeno+™ (for adenovirus) is in development. Because the “plus” assays all use a common internal control, a single nucleic acid extract can be used in any combination of tests, allowing labs tremendous flexibility. This gives labs the ability to run only the most medically-appropriate tests with the benefits of using a highly-automated, closed system real-time PCR platform.
“With the new ASR guidelines being enforced by the FDA as of September, 2008, it has become critically important for manufacturers to gain clearances for their products,” commented Tom Shannon, CEO. “By implementing a strict design control process, using skilled clinical trial site partners and working closely with the FDA throughout the process, we are proud to be a leader in the industry in earning 510(k) clearances for real-time molecular diagnostic products. Clinical trials for our next product submission, ProGastro™ Cd for Clostridium difficile have been completed and this assay will be submitted to FDA for 510(k) clearance shortly.
hMPV was discovered in 2001 by a team of Dutch researchers. Patients infected with hMPV present with symptoms of acute upper and/or lower respiratory tract infections and share the same nonspecific symptoms as many other respiratory pathogens. Cough, rhinitis, fever, otitis media and dyspnea are the most common symptoms. The overall incidence of hMPV can vary from year to year and its prevalence has been reported to range from 6.6 to 12% in patients with symptoms of respiratory infection. hMPV is responsible for a significant portion of the 150,000 children hospitalized annually in the United States for bronchiolitis, and it also affects the elderly and the immunocompromised.
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
