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Laboratory Corporation To Offer Roche’s COBAS AmpliPrep/COBAS TaqMan HCV Test

Laboratory Corporation of America Holdings announced that it is the first commercial lab to offer 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. COBAS AmpliPrep/COBAS TaqMan HCV assay can reliably measure HCV RNA levels at baseline and at the medical decision time points during treatment predicting response to HCV therapy. The product information and current guidelines of this assay 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. The objective of the HCV therapy is to accomplish the HCV RNA undetectable, and a favorable response to treatment is considered as a 2 log (base 10) drop in viral load within 12 weeks upon initiation of treatment. It is also 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.