AcroMetrix West Nile Virus External Quality Controls Selected for Procleix Clinical Trials
Benica, CA, 03 Jul 2003
AcroMetrix, a leader in providing quality control products and services for molecular and genomic diagnostics, announced today that their investigational West Nile Virus (WNV) RNA External Quality Controls were selected for use in clinical trials designed to evaluate the safety and effectiveness of a new screening test based upon the detection of WNV nucleic acid in donor blood. The WNV RNA External Quality Controls are investigational use products and will be utilized by clinical testing sites running the investigational Chiron Procleix WNV System. The Chiron Procleix HIV-1/HCV System is currently used to screen nearly 80% of the U.S. blood supply
West Nile fever is a mosquito-borne disease originating in Africa, West Asia and the Middle East that was first observed in the United States in 1999. In 2002, the Centers for Disease Control and Prevention (CDC) reported 4,156 cases of WNV infection, and 284 WNV-associated deaths, in the United States. WNV can be transmitted through blood transfusion, with at least 6, and possibly up to 33, cases of transfusion-associated WNV infection being reported in the United States during the 2002 season.
“AcroMetrix is pleased to take an active role in the effort to improve blood safety through West Nile Virus RNA testing” said Paul Neuwald, PhD, Vice President of Research and Development at AcroMetrix. “We are working closely with Chiron in this investigation to ensure that the clinical trial results accurately reflect Procleix WNV assay performance in routine blood screening.”
Frequent testing of independent quality control samples is expected to provide the clinical sites with a means of monitoring the performance of the Procleix WNV RNA detection assay. Routine use of the AcroMetrix WNV RNA External Quality Controls may enable sites to monitor day-to-day test variation, lot-to-lot performance of test kits and operator variation, with the hope of identifying increases in random or systematic error.
About AcroMetrix
AcroMetrix is a privately held biotechnology company specializing in products and services that enhance the accuracy and reliability of infectious disease testing, and is a market leader in the emerging field of quality systems for molecular and genomic diagnostics. For more information on AcroMetrix products and services please visit their web site at http://www.acrometrix.com, or call AcroMetrix at 707.746.8888 or toll free (US) at 888.746.7921.