03 Feb Prodesse's ProGastro assay submitted to FDA for 510(k) clearance
Milwaukee, Wis. – Prodesse, Inc. announced today that it has filed a submission with the U.S. Food and Drug Administration for 510(k) clearance to market its ProGastro Cd assay as an in vitro diagnostic product in the United States. Clinical trials were conducted at several clinical laboratories in the US.
They reported that ProGastro Cd was easy-to-use and that it appeared to rapidly and accurately detect toxigenic strains of Clostridium difficile. A result can be obtained in as little as 3 hours using the assay. As the first molecular C. difficile product to be CE Marked, ProGastro Cd is already being used clinically in Europe and in several studies underway in the UK.
Clostridium difficile is a major cause of healthcare-associated infections. Annually, there are over 500,000 US infections (and over 28,000 deaths) and over 800,000 infections in the European Union. In the UK, Clostridium difficile is responsible for more deaths than MRSA. Non-molecular methods of detecting this bacterium are problematic.
Prodesse Quality Officer, Kristine Schraufnagel commented, “We were pleased with the performance of our ProGastro Cd Assay in clinical trials. It easily met our clinical goals for sensitivity and specificity. In addition, we were especially delighted that there was an extremely low incidence of inhibition as it is a major concern when performing PCR with stool samples, especially for higher-throughput labs where it adversely affects workflow. As with our other clearances we worked closely with the FDA throughout the process.”
Prodesse also announced that clinical trials for its ProParaflu+ Assay (for differentiating parainfluenza 1, 2 and 3) have been completed. The FDA 510(k) submission is expected in the next 120 days. This assay will join ProFlu+ and Pro hMPV+ as the next member of the “plus” family. These assays are designed using a common internal control strategy so that 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. The ProAdeno+ Assay (for adenovirus) is in development and will begin clinical trials in the fall.
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.