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Gen-Probe requests US approval of Procleix Ultrio for hepatitis B virus screening

This article was originally published in Clinica

Executive Summary

Gen-Probe has applied to the US FDA for approval to use its Procleix Ultrio assay to screen donated blood for the hepatitis B virus (HBV). The San Diego, California company has submitted a supplemental biologics licence application (BLA) to use the assay to screen for HBV on both its semi-automated instrument platform and on the fully automated, high-throughput Tigris system. The FDA approved Procleix Ultrio to screen donated blood for HIV-1 and the hepatitis C virus (HCV) in late 2006. According to the World Health Organisation, more than 350 million people worldwide are chronically infected with HBV, with more than one million dying every year from the disease. Gen-Probe's blood screening products are marketed worldwide by Chiron, a subsidiary of pharma giant Novartis.

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