FDA approves HCV genotyping test

The FDA has approved the first test to identify the genotype of hepatitis C virus carried by a patient.

The Abbott RealTime HCV Genotype II (Abbott Molecular) uses a blood plasma or serum sample to determine the presence of HCV genotypes 1, 1a, 1b, 2, 3, 4 or 5. The fully automated test is intended for use in patients with chronic HCV infection, and has not been evaluated in pediatric or infant patients, or in those with compromised immune systems. The test is not approved to detect HCV genetic material in tissue donors or blood or blood products.

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

Alberto Gutierrez

The approval follows a review of data indicating the relationship between treatment effectiveness and HCV genotype, as well as an assessment of the test’s accuracy in determining genotype compared with a validated gene sequencing method, according to the release.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed,” Carol Brosgart, MD, clinical professor of medicine in the global health division at the University of California San Francisco, said in a separate release. “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 U.S. is a significant advancement in helping to address an important public health issue.”