TUESDAY, SEPTEMBER 27, 2016

FDA approves first genotyping test for HCV patients

The U.S. Food and Drug Administration announced the approval on Thursday of the Abbott RealTime HCV Genotype II, a test for genotyping the hepatitis C virus that a patient is carrying.

The test can differentiate HCV genotypes 1, 1a, 1b, 2, 3, 4 and 5 by using the blood plasma or serum of an infected patient. Because HCV genotypes respond differently to available drug treatments, the FDA said the test will assist healthcare professionals in figuring out the most appropriate approach for HCV treatment.

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

The Abbott RealTime HCV Genotype II is only approved for individuals with chronic HCV and is not approved for use as a screening test or diagnostic test for the presence of HCV genetic material. The test was not evaluated in pediatric patients, newborns or in patients with compromised immune systems.

The FDA approved the test, in part, based on the assessment of the test's accurate ability to distinguish between HCV viral genotypes in comparison to a validated gene sequencing method. The test is manufactured by the Des Plaines, Ill.-based Abbott Molecular Inc.

According to the U.S. Centers for Disease Control and Prevention, HCV is the most common chronic blood-borne infection the U.S. HCV is also the leading cause of liver transplants. Approximately 3.2 million people in the U.S. have a chronic HCV infection, which causes approximately 15,000 deaths in the U.S. annually.