Prodesse's Multiplex RT-PCR ProFlu+ Assay Receives FDA Clearance
| Prodesse, Inc., has received 510(k) clearance from the FDA to market its ProFlu+ Assay. |
ProFlu+ is a molecular diagnostic assay that, from a single specimen, simultaneously detects and differentiates influenza A virus, influenza B virus and respiratory syncytial virus (RSV). Not only is it the first real-time molecular diagnostic test for respiratory viruses to receive FDA clearance, but also it is the first cleared real time molecular infectious disease test to detect as many as three organisms simultaneously.
Because the ProFlu+ 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 are minimized.
Because antiviral medications are most effective when given within 48 hours of symptom onset, it is important to have a test which is both sensitive and timely. Results from the ProFlu+ Assay are available in about 3 hours. The accuracy of the ProFlu+ Assay was confirmed in a multi-site clinical study comparing results to traditional viral culture. A total of 826 patient samples were prospectively tested and the assay demonstrated an overall clinical sensitivity and specificity of 98% and 83%, respectively. The decreased specificity was the result of the ProFlu+ assay detecting more positive samples than culture. Further testing by genetic sequencing determined that 87 of the 103 samples that were positive by ProFlu+ but negative by culture were likely true positives.
"We are convinced that we made the right choice choosing real-time PCR as our core technology platform," said Tom Shannon, CEO. "Laboratorians are telling us that the big box multiplex systems are cumbersome and more appropriate for epidemiological, not clinical, applications. ProFlu+ is the first in a lineup of real time respiratory assays that we are in the process of clearing. All of these will use a common internal control so that a single nucleic acid extraction can be used with multiple assays."
"Our Pro hMPV+ for detection of human metapneumovirus is currently in clinical trials, and two additional products will shortly begin clinical trials: ProParaflu+, a multiplex assay for differentiating parainfluenza viruses and our first enteric product, ProGastro Cd for Clostridium difficile. With the new ASR guidelines finalized by the FDA in September, 2007, it has become critically important for manufacturers to gain clearances for their products. By implementing a strict design control process, using skilled clinical trial site partners and working closely with the FDA throughout the process, we hope to lead the industry in earning 510(k) clearances for molecular diagnostic products."
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Posted on January 8, 2008