ARUP Laboratories To Offer Epi proColon Epigenomics AG' Blood-Based Colorectal Cancer Screening Test
11/8/2016 10:25:52 AM
Berlin (Germany) and Germantown, MD (U.S.A.), November 8, 2016 -
Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), announced
that ARUP Laboratories (Salt Lake City, Utah) is the next major U.S.
laboratory to offer Epi proColon(R), the first and only FDA-approved blood-
based test for colorectal cancer screening.
"I am excited about the inclusion of our FDA-approved cancer screening test
Epi proColon into ARUP's comprehensive test menu," said Greg Hamilton, CEO
of Epigenomics AG. "With its broad experience in blood-based cancer testing
and its strong client network, ARUP Laboratories will continue to play an
important role in the fight against colorectal cancer in the United States.
While colorectal cancer is one of the most preventable forms of cancer,
still 1 in 3 Americans are not regularly screened. Driving patient access
to our blood-based test has the potential to significantly increase
participation rates in colorectal cancer screening."
"ARUP Laboratories is delighted to offer the Epi proColon test for
colorectal cancer screening to our patients," said Dr. Edgar Braendle, ARUP
President and CEO. "In 2010, ARUP was one of the first two labs to offer
blood-based testing for colorectal cancer based on the Septin 9 biomarker.
We were eager to have the opportunity to transition our testing to the
newly FDA approved test. Blood-based colorectal cancer testing has the
capability of reaching those patients who have been offered and declined
other screening methods. Unlike stool-based testing, the Epi proColon test
utilizes a routine blood specimen collected in the physician's office."
1 in 3, or approximately 23 million Americans remain unscreened for
colorectal cancer. A blood test is an acceptable testing method in
healthcare. A blood test mitigates the typical screening barriers such as
patient preparation and medication modifications associated with
colonoscopy and handling of stool sample. Epi proColon is intended for the
unscreened patient population who are unwilling or unable to complete
typical screening methods (colonoscopy or stool tests).
About colorectal cancer (CRC)
The American Cancer Society projects there will be over 134,000 new
diagnosed cases of colorectal cancer, and almost 50,000 deaths, from
colorectal cancer in 2016 in the United States. Colorectal cancer remains
the second-leading cause of cancer death in the United States. Although
screening and early detection of colorectal cancer can save lives, about 35
percent of eligible U.S. patients are not being regularly screened. While
the 5-year survival rate for early colorectal cancer (stage I) is 90%, only
four-out-of-ten cases are diagnosed at this early stage. According to the
American Cancer Society, this is in part due to the underuse of screening.
About Epi proColon
Epi proColon is indicated for colorectal cancer screening in average-risk
patients who are unwilling or unable to perform colorectal cancer screening
by colonoscopy and stool-based methods.
For patients, the test only requires a simple blood sample drawn as part of
routine healthcare provider visits. There are no dietary restrictions or
alterations in medication required for the test. The sample will be
analyzed at a national or regional diagnostic laboratory.
Epi proColon is an in-vitro PCR (polymerase chain reaction) assay for the
qualitative detection of Septin9 gene methylation in DNA isolated from the
patient's plasma. Cytosine residues of the Septin9 gene are methylated in
colorectal cancer tissue, but not in normal colon mucosa. This tumor-
specific methylation pattern can be used to detect cell-free DNA shed into
the blood stream by tumor cells. Detection of colorectal cancer-derived DNA
in blood plasma using the Septin9 methylation biomarker was demonstrated in
multiple clinical studies, to be a reliable indicator of the presence of
Clinical evidence of Epi proColon
Epi proColon received FDA approval based on demonstration of safety and
efficacy, as established in clinical studies. The test has also
demonstrated its potential to increase participation rates in colorectal
The approval was based on multiple trials. In the performance evaluation
trial using the PRESEPT prospective collection from 7.941 average risk
patients (NCT00855348), samples from all patients with colorectal cancer or
advanced adenomas, and a stratified random collection of patients with
small polyps or no evidence of disease were blinded, randomized to batches
and tested at independent laboratories. In this study, the test detected
68% of all cancer cases at 80% specificity. In a second study, conducted
head-to-head against FIT, it was shown that Epi proColon is statistically
non-inferior to FIT, a USPSTF recommended method in detecting colorectal
cancer. Additionally, in the ADMIT (Adherence to Minimally Invasive
Testing) trial, it was demonstrated that blood-based testing with Epi
proColon has the potential to increase compliance with colorectal cancer
screening, compared to FIT stool-based testing. In the ADMIT trial, Epi
proColon reached an adherence rate of 99.5% among previously screening
For more information on Epi proColon, visit www.epiprocolon.com.
About ARUP Laboratories
Founded in 1984, ARUP Laboratories is a leading national reference
laboratory and a nonprofit enterprise of the University of Utah and its
Department of Pathology. ARUP offers more than 3,000 tests and test
combinations, ranging from routine screening tests to esoteric molecular
and genetic assays. ARUP serves clients across the United States, including
many of the nation's top university teaching hospitals and children's
hospitals, as well as multihospital groups, major commercial laboratories,
group purchasing organizations, military and other government facilities,
and major clinics. In addition, ARUP is a worldwide leader in innovative
laboratory research and development, led by the efforts of the ARUP
Institute for Clinical and Experimental Pathology(R).
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
detection of colorectal cancer. Epi proColon has received approval from the
U.S. Food and Drug Administration (FDA) and is currently marketed in the
United States, Europe, and China and selected other countries.
Epigenomics' second product, Epi proLung(R), is in development as a blood-
based test for lung cancer detection.
For more information, visit www.epigenomics.com.
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