Laboratory Corporation of America said this week that it is offering Roche's Cobas AmpliPrep/Cobas TaqMan HCV test, v2.0.
LabCorp said it is the first major clinical reference laboratory to offer the test, and as such can now provide physicians with a quantitative HCV viral load assay that has a lower limit of detection and quantification (15 international units/mL) than existing qualitative HCV assays (10-50 IU/mL). Viral load determinations influence decisions related to many aspects of antiviral HCV therapy, including treatment selection and adjustments. Following treatment initiation, periodic measurements of HCV viral load allows the clinician to assess the success of treatment.
Roche received approval for the Cobas AmpliPrep/Cobas TaqMan HCV test, v2.0, in March (PCR Insider, 3/7/2013). The assay is designed for use on Roche's fully automated Cobas AmpliPrep/Cobas TaqMan system, a platform for viral load monitoring of multiple infectious diseases. The system can be combined with the Cobas p 630 instrument, which provides an integrated pre-analytical primary tube handling solution.
The US Food and Drug Administration has approved Abbott's RealTime HCV Genotype II assay, the first genotyping test for hepatitis C patients approved by the agency.
The assay can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5 using a sample of an infected patient’s blood plasma or serum, and will aid health care professionals in determining the appropriate approach to treatment. Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes, FDA said.
Abbott's test is approved for individuals known to be chronically infected with HCV. 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 newborns or pediatric patients, or in patients with compromised immune systems.
The FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test's accuracy in differentiating specific HCV viral genotypes compared to a validated gene sequencing method, the agency said. The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.
In a statement, John Coulter, vice president of molecular diagnostics at Abbott, said that the newly approved assay "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."
Last month, FDA approved Abbott's RealTime HCV assay fro measuring hepatitis C viral load (PCR Insider, 5/19/2013).