For Immediate Release
Prodesse Releases CE Marked ProFlu+™ Assay in Europe
A real-time multiplex PCR assay for
detection and differentiation of key respiratory viruses
WAUKESHA, WI (October 10, 2007) – Prodesse, Inc. announced today the commercial release of its CE Marked ProFlu+™ Assay for European and other customers outside the US. ProFlu+ rapidly and accurately detects Influenza A virus, Influenza B virus and Respiratory Syncytial Virus (RSV) in a single reaction. Clinical trial sites have reported that the real-time technology used in ProFlu+ makes the detection process far easier than culture. The ProFlu+ Assay yields answers in 3 hours while culture can take from a few days to as long as two weeks.
Prodesse CEO Tom Shannon commented, “We were very pleased with the performance of ProFlu+ in our clinical trials, and we expect to be submitting our application for FDA 510(k) clearance within a few weeks. Our clinical trial sites all reported the product is easy-to-use. We expect our EU customers will find they can dramatically reduce the effort they currently expend on respiratory virus testing while improving the quality and timeliness of their results.”
Influenza is a serious disease worldwide. According to CDC, in the US, influenza occurs in 5 to 20% of the population annually. It typically results in over 200,000 hospitalizations and approximately 36,000 deaths each year. Most susceptible are infants, young children, the elderly and the immunocompromised. Like influenza, RSV also causes lower respiratory tract infections and is a frequent cause of pneumonia and bronchiolitis in infants. Almost all children have had an RSV infection by the age of three. Hospitalization occurs in between 0.5% and 2.0% of infants and young children. In addition, some studies have shown that RSV is a common cause of respiratory illness in adults and probably causes more deaths in adults than children.
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 research use only kits worldwide, CE Marked in vitro diagnostic kits outside the US , FDA 510(k) cleared products worldwide and analyte specific reagents in the US . Analyte specific reagents can be used by CLIA certified laboratories to develop assays for detecting infectious organisms. The company’s products can be used on multiple nucleic acid extraction and PCR detection 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