First FDA-Approved Hepatitis C Genotyping Test Now Available

A US Food and Drug Administration (FDA)-approved test for Hepatitis C genotyping has now been introduced to improve clinical outcomes by providing physicians with information enabling a more personalized, targeted diagnosis and treatment path.

Abbott Molecular of Abbott Laboratories (Abbott Park, IL, USA) provides its FDA-approved “RealTime HCV Genotype II” assay to determine the specific type or strain of the Hepatitis C virus (HCV) in HCV-infected individuals. The Abbott test is run on the automated m2000 platform, providing laboratories with improved workflow efficiency to meet the increased demand.

An estimated 3.2 million persons in the USA have chronic HCV infection. According to the Centers for Disease Control and Prevention (CDC), more than 75% of adults with Hepatitis C were born between 1945 and 1965 and most are unaware that they are infected. Since this group is 5 times more likely to be infected, in 2012 the CDC recommended that all baby boomers get an initial test for HCV. Once a patient is diagnosed with HCV, a physician would then order a Hepatitis C genotype test. “When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the US is a significant advancement in helping to address an important public health issue," said HIV and viral hepatitis expert Carol Brosgart, MD and clinical professor of medicine at the Division of Global Health, University of California San Francisco.

"The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of Hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies," said John Coulter, vice president, Molecular Diagnostics, Abbott.

Related Links:
Abbott Laboratories
RealTime HCV Genotype II Assay