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ViroSeq Gets FDA Clearance for use on ABI s 3700 DNA Analyzer

NEW YORK, June 25 - Celera Diagnostics today said that the US Food and Drug Administration has granted an additional marketing clearance for the company's ViroSeq HIV-1 genotyping system, a molecular diagnostic.


The 510(k) clearance covers the use of the ViroSeq system with the ABI Prism 3700 DNA analyzer, a product sold by Celera of Alameda, Calif., a joint venture between Applied Biosystems Group, Celera Genomics of Applera, and Abbott Laboratories. Abbott distributes the test, which is used to monitor and treat HIV infection.


The FDA cleared the ViroSeq system for marketing in December as an in vitro  diagnostic. ViroSeq uses DNA sequencing technology to identify strains of the HIV-1 virus, targeting regions of the viral genome associated with drug-resistant mutations. Some 150,000 HIV genotyping tests are conducted each year, according to Celera.
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