Chiron Corporation and Gen-Probe Incorporated announced that the Procleix Ultrio Assay for use on the Procleix Tigris System has been granted the CE (Conformite Europeene) Mark in accordance with Directive 98/79/EC. With the CE Mark, the companies can now proceed with the commercialization of the Procleix Tigris System in the European Union, as well as in other parts of the world that accept the CE Mark. The fully automated, high-throughput Procleix Tigris System can process 1,000 blood samples in under 14 hours, facilitating testing in smaller pool sizes and individual donor testing.
"The launch of the Procleix Tigris System outside the United States is an important milestone for the Chiron/Gen-Probe partnership," said Gene Walther, acting president, Chiron Blood Testing. "The Procleix Ultrio Assay and the Procleix Tigris System provide a powerful combination of convenience and productivity. As we move into 2005, we expect that the Procleix Tigris System, in conjunction with the Procleix Ultrio Assay, will provide blood centers throughout the European Union with the means to increase productivity and efficiency of their blood screening."
"The Procleix Tigris System will revolutionize the blood screening industry with its state-of-the-art automation, throughput and process control," said Niall Conway, Gen-Probe's executive vice president, sales and operations. "In addition, the European launch of the system with the Procleix Ultrio Assay will be an important growth driver for Gen-Probe in 2005."
The approval allows the already CE Marked Procleix Ultrio Assay to be run on the fully automated, high-throughput Procleix Tigris System. The Procleix Ultrio Assay was developed to simultaneously detect human immunodeficiency virus, type 1 (HIV-1), hepatitis C virus (HCV) and hepatitis B virus (HBV) in specimens from donated blood, plasma, organs and tissue.