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FDA Approves the First Hepatitis C Genotype Test

The Food and Drug Administration has approved a rapid test to determine the genotype of an infected patient’s hepatitis C virus, allowing physicians to better tailor therapy.

The RealTime HCV Genotype II can differentiate between genotypes 1, 1a, 1b, 2, 3, 4, and 5.

"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," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement.

The diagnostic, manufactured by Abbott Molecular, is approved only for individuals known to be chronically infected with HCV. It is not meant to be used as a screening test or to detect HCV in blood, blood products, or tissue donors, said the FDA.

The agency also noted that the RealTime test has not been evaluated in newborns or pediatric patients, or in the immunocompromised.

The Centers for Disease Control and Prevention estimates that 3.2 million Americans are chronically infected with HCV. It is the most common chronic bloodborne infection and the leading cause of liver transplants, according to the CDC.

The CDC recently urged HCV testing for all Americans born between 1945 and 1965. The FDA said it based its approval of the Abbott test partly by assessing its accuracy in differentiating specific HCV viral genotypes, compared with a validated gene sequencing method. The agency said it also reviewed data that demonstrated the relationship between HCV genotype and effectiveness of drug therapy.

The Abbott diagnostic would be ordered after an initial HCV confirmatory test, said the company. The RealTime test runs on an automated platform, "which provides laboratories substantial improvements in workflow efficiency to meet the increased demand," the company said in a statement.

"When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective," said Dr. Carol Brosgart of the division of global health at the University of California, San Francisco, in the Abbott statement. "The introduction of this test for broad use in the United States is a significant advancement in helping to address an important public health issue."

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