"We are pleased that we've been able to meet the needs of our customers by accelerating the availability of the Procleix® TIGRIS® System under IND," said Andrew Heaton, MD, vice president and chief medical officer, Chiron Blood Testing. "The Procleix TIGRIS system is the first fully automated NAT system available for blood screening, and its use with the Procleix WNV Assay will allow for maximum sensitivity by enabling individual donor testing and would bring a new level of quality assurance in detecting potential transfusion-transmitted viruses like WNV."
"Our TIGRIS System offers blood centers revolutionary levels of automation, throughput and process control," said Jim Godsey, PhD, executive vice president of development, Gen-Probe. "These attributes are especially important when testing of individual donor samples is warranted to safeguard the nation's blood supply from viruses such as
Blood centers using the Procleix WNV Assay and experiencing a large number of WNV-positive donations have developed algorithms to determine when testing should be moved from pools of 16 to individual donor testing, which offers the best opportunity to detect the presence of the virus. Testing with the Procleix WNV Assay on the Procleix TIGRIS System is planned for epidemic areas at target sites in
In addition, a pivotal clinical trial for the Procleix WNV Assay is currently being conducted at five
Separately, a clinical trial for the Procleix® Ultrio Assay on the Procleix TIGRIS® System started in February 2004. The Procleix Ultrio Assay is specifically designed for the simultaneous detection of human immunodeficiency virus 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissues. Clinical trials for the Procleix TIGRIS System have been completed, with FDA submissions for the TIGRIS System for blood screening and for the Ultrio assay planned for later in 2004.
About Procleix® Assays and Systems
Procleix Assays and Systems incorporate state-of-the-art amplified NAT technology to detect viral RNA and DNA in donated blood and plasma during the very early stages of infection, when those infectious agents are present but cannot be detected by immunodiagnostic tests. The Procleix® HIV-1/HCV Assay, developed in collaboration with Gen-Probe Incorporated, has been commercially available in