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27.04.2016 07:49:41
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DGAP-News: Epigenomics AG
DGAP-News: Epigenomics announces commercial launch of Epi proColon(R) in the U.S.
Epi proColon(R) was recently approved by the U.S. Food and Drug Administration (FDA) for colorectal cancer screening in average-risk patients who are non-compliant to other screening tests such as colonoscopy and FIT.
For patients, the test only requires a simple blood sample to be 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 local or regional diagnostic laboratory.
"We are very excited to be able to start the commercialization of Epi proColon(R) as the first and only approved blood-based colorectal cancer screening test just two weeks after its approval by the US FDA," said Dr. Thomas Taapken, CEO/CFO of Epigenomics. "I would like to thank our employees and our partners at Polymedco for their commitment and hard work to make this happen so quickly. We look forward to making Epi proColon(R) available through laboratories nationwide."
According to the American Cancer Society, there are projected to 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.
About Epi proColon(R)
Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT).
Epi proColon(R) has received FDA approval based on demonstration of safety and efficacy as established in three major clinical studies. The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening.
Epi proColon(R) 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 has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer. Epi proColon(R) has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.
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(R), is a blood-based screening test for the early detection of colorectal cancer. Epi proColon(R) has recently 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.
About Polymedco
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.
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Contact Epigenomics AG
Peter Vogt Vice President Corporate Communications & Investor Relations Epigenomics AG Geneststraße 5 10829 Berlin Phone +49 (0) 30 24345 386 ir@epigenomics.com
http://www.epigenomics.com
For U.S. press inquiries:
Deanne Eagle Planet Communications Tel: (917) 837-5866 deanne@planetcommunications.nyc
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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27.04.2016 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, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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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 End of News DGAP News Service ---------------------------------------------------------------------------
458105 27.04.2016
DGAP-News: Epigenomics AG / Key word(s): Product Launch
Epigenomics announces commercial launch of Epi proColon(R) in the U.S.
27.04.2016 / 07:49
The issuer is solely responsible for the content of this announcement.
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Press release
Epigenomics announces commercial launch of Epi proColon(R) in the U.S.
Berlin (Germany) and Germantown, MD (U.S.A.), April 26, 2016 - Epigenomics
AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American
cancer molecular diagnostics company, announced today that Epi proColon(R),
its blood-based test for colorectal cancer screening, has now been made
commercially available in the U.S. under a joint commercialization
agreement with Polymedco, Inc.
Epi proColon(R) was recently approved by the U.S. Food and Drug Administration (FDA) for colorectal cancer screening in average-risk patients who are non-compliant to other screening tests such as colonoscopy and FIT.
For patients, the test only requires a simple blood sample to be 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 local or regional diagnostic laboratory.
"We are very excited to be able to start the commercialization of Epi proColon(R) as the first and only approved blood-based colorectal cancer screening test just two weeks after its approval by the US FDA," said Dr. Thomas Taapken, CEO/CFO of Epigenomics. "I would like to thank our employees and our partners at Polymedco for their commitment and hard work to make this happen so quickly. We look forward to making Epi proColon(R) available through laboratories nationwide."
According to the American Cancer Society, there are projected to 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.
About Epi proColon(R)
Epi proColon(R) is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests (FIT).
Epi proColon(R) has received FDA approval based on demonstration of safety and efficacy as established in three major clinical studies. The test has also demonstrated its potential to significantly increase participation rates in colorectal cancer screening.
Epi proColon(R) 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 has been demonstrated in multiple clinical studies to be a reliable indicator of the presence of colorectal cancer. Epi proColon(R) has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.
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(R), is a blood-based screening test for the early detection of colorectal cancer. Epi proColon(R) has recently 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.
About Polymedco
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.
- ends -
Contact Epigenomics AG
Peter Vogt Vice President Corporate Communications & Investor Relations Epigenomics AG Geneststraße 5 10829 Berlin Phone +49 (0) 30 24345 386 ir@epigenomics.com
http://www.epigenomics.com
For U.S. press inquiries:
Deanne Eagle Planet Communications Tel: (917) 837-5866 deanne@planetcommunications.nyc
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.
---------------------------------------------------------------------------
27.04.2016 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, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de
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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 End of News DGAP News Service ---------------------------------------------------------------------------
458105 27.04.2016
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