Hepatitis C

FDA approves HCV qualitative assay

Published in Blood Weekly, December 12th, 2002

Gen-Probe Incorporated (GPRO) announced that the U.S. Food and Drug Administration (FDA) has granted approval of its premarket application (PMA) for its Qualitative HCV Assay.

Gen-Probe developed this amplified assay based on its proprietary Transcription-Mediated Amplification (TMA) technology. The Qualitative HCV Assay, which will be marketed by Bayer Corporation, Diagnostics Division, under the brand name Versant, is to be used by clinical laboratories to detect the presence of HCV in human plasma or serum in patients suspected to be actively infected with HCV or with evidence of the HCV infection.

Positive results from a clinical study of...

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Source: Blood Weekly (2002-12-12)

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