For Immediate Release
Prodesse Begins Clinical Trial for ProFlu+
A Multiplex PCR Assay for Detection of Key Respiratory Viruses
WAUKESHA, WI (February 12, 2007) – Prodesse, Inc. announced today that several leading healthcare institutions have begun clinical trials of its recently developed ProFlu+, a multiplex PCR assay for the detection and differentiation of Influenza A virus, Influenza B virus and Respiratory Syncytial Virus (RSV). Prodesse has worked closely with the FDA on the clinical study design and expects to submit its application for 510(k) clearance shortly after completion of clinical trials this spring.
Current FDA cleared methods for detection of these three key respiratory viruses suffer from a variety of problems – some lack sensitivity, some lack clinically useful turnaround time and some require subjective interpretation. Prodesse’s product is intended to address all of these problems, and it has necessary enzymes incorporated so that labs will find it very ‘user-friendly’.
Prodesse CEO Tom Shannon commented, “We expect the clinical trials to show that ProFlu+ is an improvement over the current methodologies used by labs for detection of these key respiratory viruses. Because our product is designed for use with existing automated platforms, we expect 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.”
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