First HCV genotyping test approved by US FDA
The first hepatitis C virus genotyping test in the United States has been approved by the FDA. Made by Abbott Laboratories, the fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the hepatitis C (HCV) virus present in the blood of an HCV-infected individual.
The test has been approved for individuals known to be chronically infected with HCV and not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors.
Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.
HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University of California San Francisco.
John Coulter, vice president, Molecular Diagnostics, Abbott.
HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants, according to the Centers for Disease Control and Prevention.
FDA approves Abbot Labs hepatitis C genotype test (Bloomberg Businessweek)
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