FDA Approves Hepatitis C Virus Genotyping Test for Physicians to Target Treatment

To help physicians take a step towards more personalized treatment for patients infected with hepatitis C virus (HCV), the US Food and Drug Administration today approved a fully automated test that can distinguish the seven major HCV genotypes in an infected patient.

In a statement, Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said the new test “can help physicians gain an understanding of a patient’s HCV status,” and he added that such knowledge is “an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.”

As the first FDA-approved HCV genotyping test for chronically infected US patients, the RealTime HCV Genotype II test, which is manufactured by Abbott’s molecular diagnostics arm, identifies the presence of HCV types 1, 1a, 1b, 2, 3, 4, and 5 in a patient’s blood plasma or serum sample — information health care professionals can use to select a targeted treatment path for the strain and improve patient outcomes, the FDA said.

“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,” said Carol Brosgart, MD, a clinical professor of medicine at the University of California San Francisco’s Division of Global Health, in a press release from Abbott. “The introduction of this test for broad use in the US is a significant advancement in helping to address an important public health issue.”

Supporting the designation of HCV as a public health issue, the Centers for Disease Control and Prevention reports that the virus is the most common chronic blood-borne infection in the country, as an estimated 3.2 million US residents have chronic HCV, and approximately 15,000 people die each year as a result of the infection. HCV is also the leading cause of liver transplants, since it can lead to severe liver damage, liver failure, and liver cancer if left untreated.

According to the FDA, the accuracy of Abbott’s RealTime HCV Genotype II test in differentiating HCV genotypes was compared to a validated gene sequencing method, and the agency reviewed data demonstrating HCV genotype’s relationship to drug treatment’s effectiveness. Both results ultimately formed part of the basis for the FDA’s stamp of approval today, the agency said.