DGAP-News: Congressman Donald M. Payne, Jr. Introduces Bipartisan 2016 Colorectal Cancer Detection Act


DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
Congressman Donald M. Payne, Jr. Introduces Bipartisan 2016 Colorectal
Cancer Detection Act

29.09.2016 / 20:03
The issuer is solely responsible for the content of this announcement.

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Press release

Congressman Donald M. Payne, Jr. Introduces Bipartisan 2016 Colorectal
Cancer Detection Act

Legislation aims to provide coverage under the Medicare program for FDA-
approved
qualifying colorectal cancer screening blood-based tests

Berlin (Germany) and Germantown, MD (U.S.A.), September 29, 2016 -
Congressman Donald M. Payne, Jr. (D-NJ), today introduced the ''Donald
Payne Sr. Colorectal Cancer Detection Act of 2016'' at a panel discussion
held in Washington D.C. The bipartisan initiative, led on the Republican
side by Congressman Charles Dent (R-PA), aims to provide coverage under the
Medicare program for FDA-approved qualifying colorectal cancer (CRC)
screening blood-based tests.

"Colorectal cancer is one of the most preventable forms of cancer, yet it
remains the second leading cause of cancer death in the United States,
mainly because 1 in 3 Americans do not stay up-to-date with their
screenings. We need new and innovative tools to reach these patients," said
Congressman Donald M. Payne, Jr. "While the Food and Drug Administration
has recently approved a new blood-based screening test, which will enable
historically underserved communities to more fully participate in
screening, the Centers for Medicare & Medicaid Services reimbursement is
not yet aligned with it.  For this reason, I have introduced legislation
that would include all FDA-approved blood-based screening tests with
available screening methods and authorize equivalent CMS reimbursement. By
doing so, we can finally close the gap and screen the unscreened."

"Making sure that all patients, particularly those from historically
underserved areas, take full advantage of early detection and screening is
vitally important in the fight to prevent needless deaths from colorectal
cancer," said U.S. Rep. Charlie Dent (R-PA).  "A person's geography or
their economic status should not be the driving factor as to whether they
survive colorectal cancer.  Our bill, by formalizing CMS payment for FDA
approved tests on the market today, will better enable physicians to reach
those one in three people who are not screened today."

"We are very excited to join the mission of Congressman Payne, Jr. and
Congressman Dent to fight colorectal cancer in the United States," said
Greg Hamilton, Chief Executive Offer of Epigenomics AG. "This new
initiative is a unique opportunity to provide millions of unscreened,
underserved Americans access to colorectal cancer screening and to
ultimately save thousands of lives."

The panel entitled "Screening the Unscreened: New Approaches to Reaching
the Underserved to Prevent Colorectal Cancer" included leading experts
within the Colorectal Cancer and gastroenterology community:

"Death from colorectal cancer is preventable if caught early," said Jeffrey
Cossman, M.D., Founder of United States Diagnostic Standards, Inc. (USDS)
and Association for Molecular Pathology (AMP). "But despite decades of our
best efforts, still 1 in 3 or almost 23 million Americans are not screened.
A new, cost-effective DNA blood-test for colorectal cancer screening is a
unique opportunity to overcome existing testing barriers and disparities.
There is overwhelming evidence that underserved and rural populations
suffer most from low colorectal cancer screening rates."

"There is clear evidence that lack of colorectal cancer screening results
in a higher incidence of late-stage colorectal cancer disproportionately in
ethnic minorities," said Amar R. Deshpande, M.D., Vice Chief for Education,
Division of Gastroenterology (Department of Medicine), University of Miami.
"A patient accepted blood test covered under Medicare could benefit these
communities and thereby reduce the number of related deaths."

"As a practicing primary care physician, the importance of regular
colorectal cancer screening cannot be overemphasized," said Raymond
Nungesser, M.D., Family Medicine Practitioner, Geisinger Health System.
"Unfortunately, barriers exist for many of my rural patients. A blood test
for colorectal cancer screening addresses those barriers and provides
medical professionals with a new tool in the fight against one of the
deadliest cancers in the United States."

"The advances in molecular diagnostics have provided us with a disruptive
technology to reach the 1 in 3 who have avoided colorectal cancer
screening," said Nicholas Potter, PhD., Executive Vice-President of
Clinical Affairs, Molecular Pathology Laboratory Network. "The introduction
of a novel DNA blood test has the potential to increase compliance with
colorectal cancer screening, as demonstrated in clinical studies."

"We are extremely pleased by Congressman Donald Payne's colorectal cancer
screening initiative," said Michael Sapienza, Chief Executive Officer, The
Colon Cancer Alliance. "Improving access to new technologies for colorectal
cancer screening will contribute to reaching 80% screening rates by 2018
and to fulfilling our mission of ultimately knocking out colorectal
cancer."

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
colorectal cancer.

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
cancer screening.

The approval was based on a major clinical validation study with
approximately 8,000 individuals at average risk to develop colorectal
cancer. 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 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
resistant participants.

For more information on Epi proColon, visit www.epiprocolon.com.

About Epigenomics

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.

Contact in the U.S.
David Bull
Director of Marketing
Phone: 240.912.6430
David.Bull@Epigenomics.com

Contact Epigenomics AG
Peter Vogt
Vice President Corporate Communication & Investor Relations
Epigenomics AG
Geneststraße 5
10829 Berlin
Phone +49 (0) 30 24345 386
ir@epigenomics.com

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.


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29.09.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
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   Language:    English                                                    
   Company:     Epigenomics AG                                             
                Geneststraße 5                                             
                10829 Berlin                                               
                Germany                                                    
   Phone:       +49 30 24345-0                                             
   Fax:         +49 30 24345-555                                           
   E-mail:      ir@epigenomics.com                                         
   Internet:    www.epigenomics.com                                        
   ISIN:        DE000A11QW50                                               
   WKN:         A11QW5                                                     
   Listed:      Regulated Market in Frankfurt (Prime Standard); Regulated  
                Unofficial Market in Berlin, Dusseldorf, Munich,           
                Stuttgart, Tradegate Exchange                              
 
 
   End of News    DGAP News Service  
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