FDA Approves First Hepatitis C Genotype Test

The U.S. Food and Drug Administration approved a test that identifies the genotype of hepatitis C virus (HCV) a patient carries.

The test called HCV Genotype II made by Abott Laboratories helps to differentiate between various genotypes or stains of hepatitis C using the sample of the infected person's blood plasma or serum. This test can help differentiate genotypes 1, 1a, 1b, 2, 3, 4 and 5. This test makes it easy for the health care professionals to determine the right method to treat the victim. Different HCV genotypes respond differently to the available drug therapies.

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

A U.S. Centers for Disease Control and Prevention report states that one of the most common chronic blood borne infection in the U.S. is HCV that leads to damage of liver, liver cancer and liver failure. About 3.2 million people in the U.S. are believed to be victims of chronic HCV and 15,000 people die due to this.

It is blood and other bloody fluids that help in the transmission of the HCV. Those users who rely on injection drugs and share needles are at a high risk of HCV infection.

The test is approved for those who are infected with HCV.