BURLINGTON, N.C.--(BUSINESS WIRE)--Feb. 12, 2009--
Laboratory Corporation of America® Holdings (LabCorp®)
(NYSE:LH) announces that it 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
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
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, Ph.D., 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."
About LabCorp®
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. With annual
revenues of $4.5 billion in 2008, over 28,000 employees worldwide, and
more than 220,000 clients, LabCorp offers clinical assays ranging from
routine blood analyses to HIV and genomic testing. LabCorp combines its
expertise in innovative clinical testing technology with its Centers of
Excellence: The Center for Molecular Biology and Pathology, National
Genetics Institute, Inc., ViroMed Laboratories, Inc., The Center for
Esoteric Testing, Litholink Corporation, DIANON Systems, Inc., US
LABS, and Esoterix and its Colorado Coagulation, Endocrine Sciences, and
Cytometry Associates laboratories. LabCorp conducts clinical trial
testing through its Esoterix Clinical Trials Services division. LabCorp
clients include physicians, government agencies, managed care
organizations, hospitals, clinical labs, and pharmaceutical companies.
To learn more about our organization, visit our Web site at: www.labcorp.com.
Each of the above forward-looking statements is subject to change
based on various important factors, including without limitation,
competitive actions in the marketplace and adverse actions of
governmental and other third-party payors. Actual results could
differ materially from those suggested by these forward-looking
statements. Further information on potential factors that could affect
LabCorp’s financial results is included in the Company’s Form 10-K for
the year ended December 31, 2007, and subsequent SEC filings, and
will be available in the Company’s Form 10-K for year ended December 31,
2008, when filed.
Source: Laboratory Corporation of America(R) Holdings
LabCorp
Investor/Media: Bill Bonello, 336-436-7732
Company
Information: www.labcorp.com
