Laboratory Corporation of America Holdings (LabCorp) is the first national clinical laboratory to offer HCV PCR testing using a newly FDA approved assay, the Roche COBAS AmpliPrep/COBAS TaqMan HCV Test. This assay is intended to be used as an aid in managing HCV-infected individuals undergoing antiviral therapy. The assay can reliably measure HCV RNA levels at baseline and at the medical decision time points during treatment predicting response to HCV therapy. Current guidelines and product information for the FDA-approved peginterferons support the importance of measuring HCV RNA levels prior to treatment at baseline, at intervals during treatment to assess antiviral response, and after treatment is completed to assess the efficacy of the treatment.
Since the goal of HCV therapy is to achieve HCV RNA undetectable, and a favourable response to treatment is considered as a 2 log (base 10) drop in viral load within 12 weeks upon initiation of treatment, it is important that viral Nucleic Acid monitoring assays provide a high level of sensitivity and a broad reportable range. The Roche COBAS AmpliPrep/COBAS TaqMan HCV Test measures HCV RNA levels as low as 43 international units (IU) per mL, and can detect as positive more than 95% of samples containing as few as 13.9 IU/mL (in plasma) and 10.5 IU/ml (in serum) and as high as 69,000,000 IU/mL in a single specimen.
"Therapeutic decisions are influenced by both pre- and post-treatment HCV viral loads. The Roche COBAS AmpliPrep/COBAS TaqMan HCV Test can measure HCV RNA levels from 43 to 69 million IU/mL," said Andrew Conrad, chief scientist of LabCorp. "I am pleased that LabCorp's leading position in hepatitis testing allows us to be the first laboratory to make this enhanced test available."
"An FDA approved NAT test has long been the standard for managing patients with HIV and we are pleased to bring that high level of standardized viral load measurement to Hepatitis C treatment," said Whitney Green, senior vice president of Commercial Operations, US Molecular Diagnostics at Roche Diagnostics. "This new Roche Real-Time PCR test enables laboratories to deliver reliable healthcare information with ease, aiding physicians in the management of patient response to treatment."
Laboratory Corporation of America Holdings, a S&P 500 company, is a pioneer in commercializing new diagnostic technologies and the first in its industry to embrace genomic testing.