LabCorp Announces Full Portfolio of Hepatitis C Virus Drug Resistance Assays

Laboratory Corporation of America® Holdings (LabCorp®) LH today announced the launch of two new Hepatitis C Virus (HCV) drug resistance assays. The HCV NS5A and NS5B Drug Resistance Assays expand LabCorp's portfolio of HCV resistance tests that includes HCV GenoSure® NS3/4A, which was launched in 2011. These tests are available through Monogram Biosciences, a member of the LabCorp Specialty Testing Group, and a leader in the development and commercialization of innovative antiviral diagnostics. Chronic viral hepatitis is the leading cause of liver failure, liver transplantation and hepatocellular carcinoma. The U.S. Centers for Disease Control and Prevention (CDC) estimates that more than three million people in the U.S., and 170 million individuals worldwide, are infected with HCV. Since 2011, the U.S. Food and Drug Administration (FDA) has approved six new drug applications for HCV treatment that include one or more direct acting antiviral (DAA) agents. DAA-based regimens have dramatically improved HCV cure rates compared to interferon-based treatment regimens, which have been standard of care for over two decades. Although DAA treatment is highly successful, DAA treatment can fail if a patient is infected with certain HCV variants that are drug resistant. LabCorp's HCV drug resistance assays provide clinicians with actionable knowledge that can guide treatment decisions. The HCV NS5B Drug Resistance Assay assesses resistance to sofosbuvir, which was approved as a single DAA in 2013 and as a co-formulation with the NS5A inhibitor, ledipasvir, in 2014. The HCV NS5A Drug Resistance Assay assesses resistance to ledipasvir. In addition, LabCorp's portfolio of HCV resistance assays can assess resistance to each component of the latest FDA-approved DAA-based regimen, which is comprised of paritaprevir, ombitasvir and dasabuvir. LabCorp's HCV DAA resistance assays are the first to be developed using state of the art next generation sequencing (NGS) technology, which features improved discrimination of small populations of drug resistant virus. The complete portfolio of LabCorp HCV drug resistance assays is also available through Monogram and for customers of Covance Drug Development to support pre-clinical development and clinical evaluation of new HCV DAA candidates. "LabCorp's launch of the HCV NS5A and NS5B Drug Resistance Assays, combined with the first-to-market HCV GenoSure NS3/4A Assay, enables clinicians to assess resistance to all of the DAA treatment regimens that have been approved by the FDA," stated Dr. Marcia Eisenberg, LabCorp Diagnostics' Chief Scientific Officer. "LabCorp's expanded HCV drug resistance testing portfolio is the latest example