LabCorp to Follow Pivotal Role in Clinical Trial of Merck’s Keytruda® by Offering PD-L1 Companion Diagnostic
October 02 2015 - 3:55PM
Business Wire
Test Launch Demonstrates that Combined
LabCorp-Covance Capabilities Make the Company Best-in-Class Partner
for Development and Commercialization of Companion Diagnostics
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:
LH) today announced the nationwide availability of a new
FDA-approved companion diagnostic, the PD-L1 IHC 22C3 pharmDx assay
by Dako, an Agilent Technologies company, to assess the eligibility
of non-small cell lung cancer (NSCLC) patients for treatment with
pembrolizumab (Keytruda).
“This significant launch powerfully demonstrates the importance
of the LabCorp-Covance combination,” said David P. King, Chairman
and Chief Executive Officer. “Our central laboratory was
exclusively responsible for testing specimens for PD-L1 expression
in the KEYNOTE-001 registration trial, and LabCorp is one of the
first laboratory providers of the PD-L1 IHC 22C3 pharmDx test. We
continue to focus on our three strategic priorities: bringing
innovative medicines to patients, using information to change the
way care is delivered, and providing world-class diagnostic
results.”
“Importantly, LabCorp’s involvement with the KEYNOTE-001
registration trial gives us experience that no other lab has in
performing and interpreting the results of this assay in a
standardized manner,” stated Dr. Steve Anderson, Chief Scientific
Officer of Covance Drug Development. “The availability of this test
reflects how our combined capabilities will support improved
patient outcomes and reduced healthcare costs by delivering world
class diagnostics and bringing innovative new medicines to
patients.”
“LabCorp’s best-in-class companion diagnostic capabilities
supported the approval of Keytruda and its companion diagnostic,”
stated Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific
Officer. “The PD-L1 IHC 22C3 pharmDx assay is an important advance
in personalized medicine that enables clinicians to determine
whether a patient with metastatic NSCLC is a candidate for this new
immuno-oncology therapy. The launch of this innovative test is
another example of our unique ability to support development and
commercialization of new companion diagnostics, helping to advance
treatment options for cancer and other diseases.”
“We are very pleased with LabCorp’s efforts to bring this
important new test to patients with metastatic non-small cell lung
cancer. As the central testing laboratory for the registration
trial, LabCorp supported the development of the therapeutic and
companion diagnostic applications for Keytruda, and will now make
this approved test for the PD-L1 biomarker available to physicians
and patients across the country,” said Dr. Eric Rubin, vice
president, Merck Research Laboratories.
According to the American Cancer Society, lung cancer is the
leading cause of cancer death in the U.S. and is the second most
commonly diagnosed cancer with an estimated 221,200 new cases
diagnosed in 2015. The vast majority of patients exhibit the
non-small cell subtype, representing 80-85% of patients, and over
half of these patients are diagnosed with metastatic or advanced
disease at initial presentation. Data from the KEYNOTE trial
recently presented at the American Association for Cancer Research
Annual Meeting and published in the New England Journal of Medicine
demonstrated that PD-L1 expression in at least 50% of non-small
cell lung tumor cells correlated with improved response rates and
progression free survival in patients treated with Keytruda.
For more information on the PD-L1 pharmDx test, contact the
Integrated Oncology customer service line at (800) 447-5816.
Keytruda is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc.
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 pro forma for the acquisition of Covance 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, and the Company’s Form 10-Q for the quarter ended June
30, 2015, 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 Company’s Form 10-K for the year ended December
31, 2014, and subsequent Forms 10-Q, under the heading MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
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LabCorp®Paul Surdez, 336-436-5076Company Information:
www.labcorp.com
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