The US Food and Drug Administration (FDA) has approved a new test developed by Abbott Molecular, Inc., that will help physicians pinpoint patients’ genotype, or strain, of hepatitis C viral infection (HCV). The Abbott RealTime HCV Genotype II test is approved for people who are known to have the infection. Abbott Molecular, Inc. specializes in molecular diagnostics and the analysis of DNA, RNA and proteins at the molecular level. It is part of the global healthcare company Abbott Laboratories, and is based in Des Plaines, IL.
Using a patient’s blood sample, the new test can distinguish between genotypes 1, 1a, 1b, 2, 3, 4, and 5. However, it has not been evaluated in children or in people with compromised immune systems (such as those with AIDS). It is not recommended as a diagnostic or screening test for the presence of HCV genetic material in blood, blood products or tissue donors.
“Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. Drug treatments for HCV vary in effectiveness, depending on a patient’s genotype. “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.”
Source: FDA news release dated June 20, 2013; Heath Day, June 20, 2013