Prodesse, Inc., has received 510(k) clearance from the FDA to market its Pro hMPV+™ Assay.

The clearance came in just under 2 months from submission. Pro hMPV+ is a molecular diagnostic assay that detects human metapneumovirus (hMPV). It is the first real-time molecular diagnostic test for hMPV to receive FDA clearance, and is the second member of Prodesse´s ‘plus´ family of respiratory virus assays to be cleared. The assay is sold with fully-paid royalties for both the organism and method, so that labs do not need to make any additional payments to patent holders. Labs currently offering home-brew molecular testing for hMPV may now be able to cut their total costs (raw materials, quality control, method and organism royalties) in half by using the Prodesse kit.

The Pro hMPV+ Assay uses real-time PCR 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.