First FDA-Approved Blood-Based Colorectal Cancer Test Offers
Alternative for Patients Non-Compliant with Existing Screening Options
BURLINGTON, N.C.–(BUSINESS WIRE)–Laboratory Corporation of America® Holdings (LabCorp®)
(NYSE: LH) today announced the launch of Epi proColon®, a
blood-based test for colorectal cancer screening that was approved on
April 13, 2016 for clinical use by the U.S. Food and Drug Administration
(FDA). Epi proColon® is the first FDA-approved DNA based
blood test for colorectal cancer. The test was developed by Epigenomics
AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and is available under
a joint commercialization agreement with Polymedco, Inc. in North
America. LabCorp, the world’s leading healthcare diagnostics company, is
the first laboratory in the U.S. to offer this FDA-approved, blood-based
colorectal cancer screening test.
“Colorectal cancer is one of the most curable diseases when detected in
its early stages and treated surgically,” said Dr. Mark Brecher, chief
medical officer for LabCorp Diagnostics. “Many people are not properly
screened because they are reluctant to collect a stool sample or undergo
a colonoscopy. Tested from a simple blood draw, Epi proColon®
is a convenient, accurate alternative for those patients who should be
screened for colorectal cancer. LabCorp is committed to delivering
world-class diagnostics, and Epi proColon® will contribute to
our mission to improve health and improve lives.”
The Epi proColon® test detects Epigenomics proprietary
Septin9 DNA methylation biomarker for colorectal cancer in cell-free DNA
circulating in blood, which has been demonstrated in multiple clinical
studies to be a reliable indicator of the presence of colorectal cancer.
The test is available immediately from LabCorp. Epi proColon®
is an important addition to LabCorp’s leading menu of integrated testing
that includes comprehensive colorectal cancer offerings.
According to the American Cancer Society, there are projected to be over
134,000 new diagnoses of colorectal cancer, and almost 50,000 deaths
from colorectal cancer in the U.S. in 2016. Approximately 23 million
people in the U.S. are identified as at-risk for colorectal cancer or
meet guidelines to be screened for this cancer remain unscreened.
Currently, approved screening options including stool testing and
colonoscopy are often viewed as inconvenient, uncomfortable or
unpleasant, and about 35% of eligible U.S. patients refuse to undergo
them. For these people and their physicians, a convenient blood test
that only requires a blood draw provides a powerful screening option
designed to improve participation in screening and can support earlier
cancer detection, resulting in improved outcomes. For patients who may
be reluctant to complete stool testing or colonoscopy, Epi proColon®
provides an alternative that can change the way care is provided and may
encourage more patients to obtain recommended screenings.
Epi proColon® is a registered trademark of
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.
Since 1980, Polymedco has evolved into a leading manufacturer, marketer,
and distributor in the clinical laboratory marketplace. Polymedco
supplies clinical diagnostic test kits that are specialized in
hematology and cancer screening. The Company is a world leader in
non-invasive colorectal cancer screening technology.
Epigenomics is a molecular diagnostics company focused on blood-based
detection of cancers using its proprietary DNA methylation biomarker
technology. The Company develops and commercializes diagnostic products
across multiple cancer indications with high medical need. Epigenomics’
lead product, Epi proColon®, is a blood-based screening test
for the early detection of colorectal cancer. Epi proColon has received
approval from the U.S. Food and Drug Administration (FDA) and is
currently marketed in Europe, China and selected other countries. For
more information, visit www.epigenomics.com.
LabCorp Legal Disclaimer
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.
Epigenomics Legal Disclaimer
This communication expressly or implicitly contains certain
forward-looking statements concerning Epigenomics AG and its business.
Such statements involve certain known and unknown risks, uncertainties
and other factors which could cause the actual results, financial
condition, performance or achievements of Epigenomics AG to be
materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements.
Epigenomics AG is providing this communication as of this date and does
not undertake to update any forward-looking statements contained herein
as a result of new information, future events or otherwise.