LabCorp Announces Availability Of Newly Approved Viral Load Assay For Hepatitis C Virus

Laboratory Corporation of America ® Holdings (LabCorp ®) (NYSE: LH) today announced that it is offering the COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0. With enhanced sensitivity, this quantitative viral load assay for Hepatitis C virus (HCV) enables more accurate assessments of response to antiviral therapy.

As the first major clinical reference laboratory 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). 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 U.S. (and 170 million worldwide) 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 U.S. 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 1945-1965, a birth cohort that CDC estimates to include a majority of HCV infected individuals in the U.S. 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.

“LabCorp is proud of its longstanding and prominent role of providing innovative and novel diagnostic tests to assist physicians in treating and managing chronic HCV infection,” said Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 is another valuable addition to the Company’s comprehensive portfolio of assays that characterize the Hepatitis C virus, disease course and the patient’s optimal treatment path.”

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