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FDA to review Chiron's HIV/HCV (hepatitis C virus) NAT (nucleic acid test):

This article was originally published in Clinica

Executive Summary

The US FDA has accepted for review Chiron's nucleic acid test (NAT) for screening donated blood for the HIV-1 and hepatitis C (HCV) viruses. The Procleix assay uses a technique called transcription mediated amplification, developed by Gen-Probe, to detect the viruses in whole blood and plasma during the earliest stages of infection. Industry data show that a NAT can reduce the time between infection and detection by 85% for HCV and 50% for HIV-1, says Chiron, of Emeryville, California. Around 50 million units of whole blood and plasma are donated and screened annually in target markets worldwide, adds the company.

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