LabCorp Announces Launch of New Companion Diagnostic for Non-Small Cell Lung Cancer

BURLINGTON, N.C.–(BUSINESS WIRE)–Laboratory Corporation of America^® Holdings (LabCorp^®)
(NYSE: LH) announced today the availability of a new application for the
companion diagnostic associated with the use of Tarceva^® for
the treatment of certain patients with non-small cell lung cancer
(NSCLC). The Roche cobas^® EGFR Mutation Test v2 is the
first blood-based test approved for clinical use in the U.S. to detect
certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC
patients. LabCorp played a key role in making the test available upon
approval by the U.S. Food and Drug Administration (FDA) and is the only
national laboratory currently offering the test.
“The availability of this test demonstrates LabCorp’s industry-leading
position in the commercialization of companion diagnostics,” said David
P. King, chairman and chief executive officer of LabCorp. “The success
and growth of our companion diagnostics business continues to
differentiate us from our competitors as we carry out our mission to
improve health and improve lives.”
The cobas^® EGFR Mutation Test v2, which was approved
by the FDA on June 1, 2016, can be used on either plasma obtained from a
routine blood collection or on tumor tissue obtained from a surgical
biopsy. The test identifies epidermal growth factor receptor (EGFR) exon
19 deletion or exon 21 (L858R) substitution mutations in patients with
NSCLC who may benefit from first-line treatment with Tarceva. The
availability of a less-invasive, blood-based test gives physicians a
powerful new treatment option for patients who may not be able to
undergo surgical biopsy or who cannot provide a tumor specimen for other
reasons.
“The FDA approval of the cobas^® EGFR Mutation
Test v2 for plasma-based testing offers a minimally invasive option for
patients with NSCLC,” said Uwe Oberlaender, Head of Roche Molecular
Diagnostics. “Partnering with key labs ensures that patients can be
tested conveniently.”
“LabCorp is pleased to add this important new test to our menu of
world-class diagnostics,” said Marcia Eisenberg, Ph.D., chief scientific
officer of LabCorp Diagnostics. “Knowledge is power for patients and
their physicians, and tests like this can help patients access targeted,
personalized treatment.”
Lung cancer is the leading cause of cancer death in the U.S. among both
men and women, accounting for about one-third of all cancer deaths, more
than the other common cancers combined (breast, prostate and colon
cancers). More than 80% of all lung cancers in the US are NSCLC, and
10%-20% of these have EGFR mutations.
The cobas^® EGFR Mutation Test v2 is now available for
patient testing nationwide from LabCorp and Integrated Oncology, a
member of the LabCorp Specialty Testing Group.
Tarceva is developed and commercialized by Astellas Pharma US in
partnership with Genentech in the United States, Chugai in Japan and
Roche in the rest of the world.
COBAS is a registered trademark of Roche.
Tarceva is a registered trademark of OSI Pharmaceuticals.
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 services and
technology-enabled solutions. With net revenue in excess of $8.5 billion
in 2015 and more than 50,000 employees in approximately 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 2016 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, 2015, and subsequent Forms 10-Q, 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, 2015, and subsequent Forms 10-Q,
under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS.