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.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. 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.”

HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, 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. Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care.”

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.



Related news:

FDA approves Abbot Labs hepatitis C genotype test (Bloomberg Businessweek)

Reference links:

Abbott press release

FDA press release

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