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Testing (HCV)

Assay to Measure Efficacy of Hepatitis C Treatment Approved

Published in Virus Weekly, October 20th, 1997

National Genetics Institute, Culver City, California, announced that its quantitative assay (Superquant HCV) for measurement of the hepatitis C virus (HCV) has been recognized by the U.S. Food and Drug Administration (FDA) as an acceptable means to assess the efficacy of a newly approved drug for the treatment of chronic HCV infection.

In a randomized controlled Phase III study of 704 chronic Hepatitis C patients treated with either Intron A (Schering Plough, Kenilworth, New Jersey) or Infergen (Amgen Inc. Thousand Oaks, California), the Superquant HCV assay was used to assess changes in viral concentrations over the course of treatment and six months after stopping...

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