Laboratory Corporation of America® Holdings (LabCorp®), Burlington, NC, is offering the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0, from Roche Molecular Diagnostics, Pleasanton, Calif.
With enhanced sensitivity, this quantitative viral load assay for Hepatitis C virus (HCV) enables more accurate assessments of response to antiviral therapy, LabCorp notes.
As the first major clinical reference lab to offer the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0, LabCorp can now provide physicians with a quantitative HCV viral load assay that has a lower limit of detection and quantification (15 IU/mL) than existing qualitative HCV assays (10-50 IU/mL), according to the company.
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.
An estimated 3.2 million people in the United States are chronically infected with HCV, which if left undiagnosed and untreated can lead to liver fibrosis, cirrhosis, and hepatocellular carcinoma. The Centers for Disease Control and Prevention (CDC) estimates that nearly half of the US HCV population is currently undiagnosed, and the slow and often silent onset of HCV disease presentation has prompted more aggressive efforts to proactively diagnose and treat HCV infection. Recently, the CDC expanded its HCV screening recommendations from “high risk behavior groups” to include all individuals born between 1945 to 1965, a birth cohort that CDC estimates to include a majority of HCV infected individuals in the United States. As part of this initiative, newly diagnosed individuals are encouraged to seek medical care and treatment for their HCV infection. The expanded availability through LabCorp of the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 is particularly timely, as the CDC recommendation is expected to result in the identification of additional HCV-infected patients and an increased demand for antiviral treatment regimens.
[Source: LabCorp]
