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Gen-Probe HIV test

This article was originally published in The Gray Sheet

Executive Summary

Firm announces FDA approval of the Aptima HIV-1 RNA qualitative genetic test Oct. 5. Gen-Probe plans to launch the test in November with its Aptima HCV RNA qualitative assay for the hepatitis C virus. The tests "fill a small-yet-important medical niche" in detecting the presence of viral genetic material, said Steve Kondor, the firm's VP-sales & marketing. The HIV test is the first approved nucleic acid test indicated to aid in the diagnosis of HIV-1 infection and to confirm infections in certain patients, according to Gen-Probe. Bayer has sold the HCV test as a co-exclusive marketer under the Versant brand since its approval in 2002. Gen-Probe has not marketed the HCV test before...

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