“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 level of treatment,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The Abbott RealTime HCV Genotype II test is approved for individuals with documented chronic HCV infection. 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 infants, pediatric patients or patients with compromised immune systems, such as individuals with HIV infection.
The FDA based its approval of the Abbott RealTime HCV Genotype II in part on an assessment of the test’s accuracy in differentiating specific HCV 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.
