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FDA approves Gen-Probe's Procleix Ultrio for HBV

This article was originally published in Clinica

Executive Summary

Gen-Probe's Procleix Ultrio assay has been approved by the US FDA for an additional indication: screening donated blood for the hepatitis-B virus (HBV). The FDA approved the firm's supplemental biologics licence application (sBLA): these usually apply to drug approvals, but Gen-Probe explained that blood is treated as a drug by the FDA. Procleix Ultrio was first approved in October 2006 to screen blood and tissue for HIV-1 and the hepatitis-C virus (see Clinica No 1227, p 15), but the initial study did not demonstrate HBV yield. The San Diego, California-based firm then carried out postmarketing studies looking at HBV yield, with its partner Chiron, and filed the sBLA in February.

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