FDA this week approved its first genotyping test for patients with hepatitis C virus (HCV), Abbott’s RealTime HCV Genotype II. The test can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5 from a blood plasma or serum sample, which FDA said “will aid health care professionals in determining the appropriate approach to treatment.”
In a statement, Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health, said that “tests such as this one can help physicians gain an understanding of a patient’s HCV status. …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.”
FDA added that RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV, not as a diagnostic or screening test for the presence of HCV. The agency said it based its approval in part “on the assessment of the test’s accuracy in differentiating specific HCV viral genotypes compared to a validated gene sequencing method.” Further, it said the test has not yet been evaluated in newborn or pediatric patients, or those who have compromised immune systems.
Said Abbott’s John Coulter, vp, molecular diagnostics: “The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies.”