Fully Automated High Throughput System Screens Donated Blood

(San Diego, CA, USA) has announced that the U.S. Food and Drug Administration (FDA) approved the company's Procleix Tigris system, a fully automated molecular diagnostics instrument, for use with the Procleix Ultrio assay. In March of 2007, the FDA approved another Gen-Probe test, the Procleix WNV (West Nile virus) assay, to screen donated blood on the Tigris system.

The system and assay also detect hepatitis B virus (HBV) in blood donations that are HBV-positive based on traditional serology tests for HBV surface antigen and core antibodies. This has not been approved at this time to screen donated blood for HBV, as the initial clinical studies were not designed to, and did not demonstrate HBV yield. Yield is defined as HBV-infected blood donations that were intercepted by the Procleix Ultrio assay, but that were initially negative based on the serology tests.

Henry L. Nordhoff, Gen-Probe's chairman, president, and CEO said, With the Procleix Ultrio assay on the Procleix Tigris system, customers can safeguard donated blood against dangerous viruses using a fully-automated, high-throughput system that maximizes the efficiency of testing and minimizes the potential for human error.

Gen-Probe's blood screening products are marketed worldwide by Chiron (Emeryville, CA, USA), a business unit of Novartis Vaccines and Diagnostics, Inc.


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