Chiron Corporation and Gen-Probe Incorporated announced that a design dossier amendment for use of the Procleix Ultrio Assay on the Procleix Tigris System has been submitted to Gen-Probe's European notified body.
This amendment would allow the already CE Marked assay to be run on the Tigris fully automated, high-throughput instrument platform, as well as on the Procleix System, the semi-automated instrument platform currently used. The Procleix Ultrio Assay was developed to simultaneously detect HIV-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissue.
"Chiron is committed to meeting our customers' needs to protect health," said Jack Goldstein, president, Chiron Blood Testing. "We have been pleased with the acceptance of the Procleix Ultrio Assay in the European Union since the assay received its CE Mark at the beginning of the year, and we believe that the Procleix Tigris System would provide blood centres in the European Union with additional convenience and throughput that comes with automation," jack added.
"One fully automated Procleix Tigris system can process 1,000 samples in about 14 hours, resulting in productivity and efficiency that is far superior to any other platform," Henry L. Nordhoff, Gen-Probe's chairman, president and chief executive officer said adding, "This level of throughput even enables individual donor testing for the hepatitis B virus, which in turn can reduce the window period between infection and detection by as much as 40 per cent compared to immunoassay tests."