The FDA has approved Gen-Probe's PROCLEIX® TIGRIS® system, the first fully automated molecular diagnostics instrument, for use with the PROCLEIX ULTRIO® assay.
The PROCLEIX TIGRIS system was approved with the PROCLEIX ULTRIO assay to screen donated blood, plasma, organs and tissue for HIV-1 and hepatitis C virus (HCV) in individual blood donations or in pools of up to 16 blood samples. 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.
As expected, the system and assay have 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. Gen-Probe and Chiron have initiated a post-marketing study to demonstrate HBV yield and gain the associated donor screening claim.
The fully automated, high-throughput PROCLEIX TIGRIS system can process 1,000 blood samples in about 14 hours, a level of productivity that facilitates testing in smaller pool sizes, which in turn can increase assay sensitivity and blood safety.
PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a trademark of Gen-Probe.