A Medical Device Daily
Gen-Probe (San Diego) reported that the FDA has approved its supplemental regulatory application to use the Procleix Ultrio assay to screen donated blood for the hepatitis B virus (HBV). The FDA had previously approved the assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV).
The assay is now approved to screen donated blood, plasma, organs and tissue for the three viruses in individual blood donations or in pools of up to 16 blood samples. The assay may be run on the enhanced semi-automated Procleix system and the fully automated, high-throughput Procleix Tigris system.
In October 2006, the FDA approved the Ultrio assay to screen donated blood, plasma, organs and tissue for HIV-1 and HCV on Gen-Probe's semi-automated instrument system. However, the Ultrio assay was not approved to screen donated blood for HBV, as the initial pivotal study for the assay was not designed to, and did not, demonstrate HBV yield. Yield is defined as HBV-infected blood donations that were intercepted by the Ultrio assay, but that were initially negative based on serology tests for HBV surface antigen and core antibodies.
Gen-Probe makes nucleic acid tests that are used primarily to diagnose human diseases and screen donated human blood.