BENICIA, Calif. -- AcroMetrix Corporation, a leading provider of quality controls for clinical diagnostic and blood testing laboratories, announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the VeriSure Pro West Nile Virus (WNV) External Quality Controls. These controls are for use with Chiron's Procleix WNV assay that was approved in December 2005 by the FDA for the testing of WNV using nucleic acid amplification. The clearance from the FDA allows these controls to be the first WNV control to be marketed and sold in the United States for "in vitro diagnostic use" in blood screening.
West Nile Virus is a mosquitoborne virus originating in Africa, West Asia, and the Middle East that was first observed in the United States in 1999. Since 2003, more than 29 million units of donated blood have been screened for WNV in the United States. AcroMetrix external quality controls for WNV were selected by Chiron 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.
"AcroMetrix provides blood screening laboratories with the most advanced and comprehensive quality system for infectious disease testing," said Michael J. Eck, CEO of AcroMetrix. "The approval of the AcroMetrix VeriSure Pro West Nile Virus external quality controls further demonstrates our commitment to help reduce the risk of transmitting this potentially deadly virus."
Frequent testing of independent quality control samples is expected to provide blood testing centers with a means of monitoring the performance of the Procleix WNV assay. Routine use of the AcroMetrix WNV external quality controls can enable sites to monitor day-to-day test variation, lot-to-lot performance of test kits and operator variation, for the purpose of identifying increases in random or systematic error.
Source: AcroMetrix Corporation