BURLINGTON, N.C.–Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announces that it will be the first national clinical laboratory to offer HBV PCR testing using a newly FDA approved assay, the Roche COBAS® TaqMan® HBV Test. This assay, to be offered next week, is intended to be used as an aid in managing patients with chronic HBV infection undergoing antiviral therapy. Since the goal of HBV therapy is to treat until circulating virus can no longer be detected it is important that viral DNA monitoring assays provide a high level of sensitivity. The Roche COBAS® TaqMan® HBV Test accurately measures HBV DNA levels as low as 29 international units (IU) per mL, and can detect as positive more than 95% of samples containing as few as 3.5 IU/mL (in plasma) and 3.4 IU/mL (in serum).

“Therapeutic decisions are influenced by both pre- and post-treatment HBV viral loads. The Roche COBAS® TaqMan® HBV Test can accurately measure HBV DNA levels from 29 to 110,000,000 IU/mL,” said Myla P. Lai-Goldman, M.D., Executive Vice President, and Chief Medical Officer 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 Hepatitis C and we are pleased to bring that high level of standardized viral load measurement to Hepatitis B treatment,” said Daniel O’Day, President and CEO of Roche Molecular Diagnostics. “This new Roche Real-Time PCR test enables laboratories to deliver reliable healthcare information with ease to allow physicians to more efficiently monitor their patients and improve treatment outcomes.”