FDA Approves First Genotyping Test for Patients With HCV

Mark Crane

June 20, 2013

The US Food and Drug Administration (FDA) today approved the first genotyping test for patients with hepatitis C virus (HCV) that can better enable physicians to select the most appropriate treatment.

Using a sample of an infected patient's blood plasma or serum, the Abbott RealTime HCV Genotype II test can differentiate HCV genotypes 1, 1a, 1b, 2, 3, 4, and 5. Because HCV genotypes respond differently to available drug therapies, knowing the type of HCV with which a person is infected can result in better patient outcomes, the FDA said in a statement.

"Tests such as this one can help physicians gain an understanding of a patient's HCV status," Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA's Center for Devices and Radiological Health, said in the statement. "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."

HCV is the most common chronic blood-borne infection in the United States and is the leading cause of liver transplants, according to the Centers for Disease Control and Prevention. 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% 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.

HCV is transmitted through blood and other bodily fluids. Injection drug users who share needles are at the highest risk for HCV infection, the FDA said. Healthcare workers stuck by needles that have been used on HCV-infected patients and children born to HCV-infected mothers are also at risk.

The new test has been 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, the FDA said.

The FDA noted in its statement that it based its approval of the test in part on the assessment of its accuracy in differentiating specific HCV viral genotypes compared with a validated gene sequencing method. The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.

The test is manufactured by Abbott Molecular Inc, in Des Plaines, Illinois.


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