LabCorp Announces Full Portfolio of Hepatitis C Virus Drug Resistance Assays
May 18 2015 - 8:45AM
Business Wire
Expanded testing services enable precision
medicine by providing clinicians with information to select optimal
treatment and characterize treatment failure
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:
LH) today announced the launch of two new Hepatitis C Virus (HCV)
drug resistance assays. The HCV NS5A and NS5B Drug Resistance
Assays expand LabCorp’s portfolio of HCV resistance tests that
includes HCV GenoSure® NS3/4A, which was launched in 2011. These
tests are available through Monogram Biosciences, a member of the
LabCorp Specialty Testing Group, and a leader in the development
and commercialization of innovative antiviral diagnostics.
Chronic viral hepatitis is the leading cause of liver failure,
liver transplantation and hepatocellular carcinoma. The U.S.
Centers for Disease Control and Prevention (CDC) estimates
that more than three million people in the U.S., and 170 million
individuals worldwide, are infected with HCV. Since 2011, the U.S.
Food and Drug Administration (FDA) has approved six new drug
applications for HCV treatment that include one or more direct
acting antiviral (DAA) agents. DAA-based regimens have dramatically
improved HCV cure rates compared to interferon-based treatment
regimens, which have been standard of care for over two
decades.
Although DAA treatment is highly successful, DAA treatment can
fail if a patient is infected with certain HCV variants that are
drug resistant. LabCorp’s HCV drug resistance assays provide
clinicians with actionable knowledge that can guide treatment
decisions. The HCV NS5B Drug Resistance Assay assesses resistance
to sofosbuvir, which was approved as a single DAA in 2013 and as a
co-formulation with the NS5A inhibitor, ledipasvir, in 2014. The
HCV NS5A Drug Resistance Assay assesses resistance to ledipasvir.
In addition, LabCorp’s portfolio of HCV resistance assays can
assess resistance to each component of the latest FDA-approved
DAA-based regimen, which is comprised of paritaprevir, ombitasvir
and dasabuvir.
LabCorp’s HCV DAA resistance assays are the first to be
developed using state of the art next generation sequencing (NGS)
technology, which features improved discrimination of small
populations of drug resistant virus. The complete portfolio of
LabCorp HCV drug resistance assays is also available through
Monogram and for customers of Covance Drug Development to support
pre-clinical development and clinical evaluation of new HCV DAA
candidates.
“LabCorp’s launch of the HCV NS5A and NS5B Drug Resistance
Assays, combined with the first-to-market HCV GenoSure NS3/4A
Assay, enables clinicians to assess resistance to all of the DAA
treatment regimens that have been approved by the FDA,” stated Dr.
Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer.
“LabCorp’s expanded HCV drug resistance testing portfolio is the
latest example of LabCorp’s commitment to deliver world-class
diagnostics to reduce treatment failures and improve patient
outcomes at lower costs.”
About LabCorp®
Laboratory Corporation of America® Holdings, an S&P 500
company, is the world’s leading healthcare diagnostics company,
providing comprehensive clinical laboratory services through
LabCorp Diagnostics, and end-to-end drug development support
through Covance Drug Development. LabCorp is a pioneer in
commercializing new diagnostic technologies and is improving
people’s health by delivering the combination of world-class
diagnostics, drug development and knowledge services. With combined
revenue proforma to the Covance acquisition in excess of $8.5
billion in 2014 and more than 48,000 employees in over 60
countries, LabCorp offers innovative solutions to healthcare
stakeholders. LabCorp clients include physicians, patients and
consumers, biopharmaceutical companies, government agencies,
managed care organizations, hospitals, and clinical labs. To learn
more about Covance Drug Development, visit www.covance.com. To
learn more about LabCorp and LabCorp Diagnostics, visit
www.labcorp.com.
This press release contains forward-looking statements including
with respect to estimated 2015 guidance and the impact of various
factors on operating results. Each of the forward-looking
statements is subject to change based on various important factors,
including without limitation, competitive actions in the
marketplace, adverse actions of governmental and other third-party
payers and the results from the Company’s acquisition of Covance.
Actual results could differ materially from those suggested by
these forward-looking statements. Further information on potential
factors that could affect LabCorp’s operating and financial results
is included in the Company’s Form 10-K for the year ended December
31, 2014, including in each case under the heading risk factors,
and in the Company’s other filings with the SEC, as well as in the
risk factors included in Covance’s filings with the SEC. The
information in this press release should be read in conjunction
with a review of the Company’s filings with the SEC including the
information in the section of the Company’s Form 10-K for the year
ended December 31, 2014, subsequent Forms 10-Q, under the heading
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS.
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Laboratory Corporation of America® HoldingsInvestor/Media
Contact:Paul Surdez, 336-436-5076www.labcorp.com
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