Laboratory Corporation of America Holdings (LabCorp) has launched a nucleic acid sequencing assay that detects NS3 and NS4A mutations and NS3 associated resistance to the hepatitis C virus (HCV) protease inhibitors.
HCV GenoSure NS3/4A analyzes the genetic sequence for the non-structural proteins NS3 and NS4A of HCV genotypes 1a and 1b that encode for an enzyme required for viral replication.
The assay specifically detects gene mutations that are associated with boceprevir and telaprevir resistance.
LabCorp Monogram Research & Development vice president Chris Petropoulos said HCV GenoSure NS3/4A represents the first in a series of HCV drug resistance assays that have been developed at Monogram Biosciences to support the clinical evaluation of HCV direct-acting antiviral (DAA) agents and their use in the management of HCV infection.
"We look forward to expanding our broad HCV assay portfolio to support the development and clinical application of additional DAA agents that target other distinct steps in the HCV replication cycle," Petropoulos said.
HCV Drug Resistance Advisory Group has highlighted the value of resistance testing at treatment baseline and failure in support of the development and clinical evaluation of new drug candidates.