FDA approves new hepatitis C genotyping test by Abbott
The U.S. Food and Drug Administration (FDA) announced Thursday the approval of the first blood test that can identify different strains of the hepatitis C virus to help guide a patient’s treatment.
The approved test, The Abbott RealTime HCV Genotype II can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5, using a sample of an infected patient’s blood plasma or serum.
Image/Abbott Media Library
Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes, according to the FDA.
“Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.”
“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining the 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, Clinical Professor of Medicine at the University of California at San Francisco.
The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is 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. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS.
According to the Centers for Disease Control and Prevention, HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants. About 3.2 million people in the United States have a chronic HCV infection and approximately 15,000 people die from the effects of the virus each year. Seventy-five to 85 percent of people infected with HCV are not able to fight off the virus on their own and develop a chronic HCV infection that requires treatment. Untreated chronic HCV infections may lead to liver cancer, severe liver damage and liver failure.
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