DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
Epigenomics AG: China FDA names Epigenomics' blood-based Septin9 colorectal
cancer test a most innovative medical product for 2015
02.05.2016 / 08:00
The issuer is solely responsible for the content of this announcement.
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Press release
China FDA names Epigenomics' blood-based Septin9 colorectal cancer test a
most innovative medical product for 2015
- Only 9 out of 7530 approved medical devices in 2015 were named
"innovative medical product" by the Chinese regulators
- Epigenomics innovative blood-based Septin9 test Epi proColon(R) for
early detection of colorectal cancer (CRC) is approved in the U.S.,
China and Europe
- CRC is a rapidly growing medical problem in China, about 290 million
people are currently eligible for screening
Berlin (Germany) and Germantown, MD (U.S.A.), May 2, 2016 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, announced today that the China Food and Drug
Administration (CFDA) has named the blood-based Septin9 test an "innovative
medical product." In the recently published "2015 Medical Device
Registration Annual Report," only nine out of 7530 approved medical devices
were granted this label by the Chinese regulators. The CFDA recognizes the
domestic initiative and significant clinical value of Septin9 tests.
Epigenomics' strategic development and commercialization partner BioChain
Institute Inc. and its affiliate BioChain (Beijing) Science and Technology
Corp., have developed the aforementioned product for the China market based
on Epigenomics' technologies. Septin9 was approved by the CFDA for
detection of colorectal cancer in 2015.
"This is excellent news and recognizes the potentially huge contribution we
can make to early colorectal cancer detection in China with our proprietary
biomarker Septin9," commented Dr. Thomas Taapken, CEO/CFO of Epigenomics.
"We are proud that, together with our strategic partner BioChain, we will
be able to give the Chinese population access to this innovative screening
opportunity."
"We are delighted to receive this official recommendation by the Chinese
regulator," Grace Tian, CEO of BioChain, added. "This gives us even more
confidence that our emphasis on early cancer detection is immensely
valuable to our society. We are excited about bringing blood-based Septin9
tests to the market in China as a truly joint effort between our two
companies and we look forward to an even more fruitful collaboration going
forward."
In 2013, BioChain and Epigenomics entered into a license agreement for the
development and commercialization of a Septin9-based colorectal cancer
blood-test in China. In 2015, BioChain successfully introduced the test
into the Chinese market. Shortly after this, the companies reported that
CRC testing, based on Epigenomics' proprietary Septin9 biomarker, was
included in the Chinese Guideline on Screening, Endoscopic Diagnosis and
Treatment of Early Colorectal Cancer (CRC).
Epigenomics' blood-based Septin9 test Epi proColon(R) is the first
CE-marked, FDA and CFDA-approved blood-based colorectal cancer detection
diagnostic. It is strongly protected by patents in multiple global
jurisdictions, including China, where both the marker itself and the
detection technology are widely protected by granted and pending patents.
Both parties, BioChain and Epigenomics remain highly committed to take all
necessary steps to enforce these IP rights that will protect and strengthen
BioChain's market exclusivity in China.
In March 2016 the collaboration between the two partners was extended for a
strategic license agreement on the development and commercialization of a
novel, blood-based lung cancer test for China.
About Colorectal Cancer in China
In accordance with various international guidelines, about 290 million
people are currently eligible for CRC screening in China and effective
testing methods that are accepted by patients will be vital to
significantly reduce CRC deaths. CRC is a rapidly growing medical problem.
In a recently published report, the independent market research firm
Decision Resources estimates that the number of incident cases of CRC in
urban areas of China will almost double between 2012 and 2022. This is
demanding for better, simple to use and affordable screening methods.
Hence, the Chinese government has elected CRC screening as one of its key
focus areas in cancer prevention.
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 BioChain
BioChain (www.biochain.com, www.biochainbj.com) is a pioneer of molecular
genetics diagnostics in the US and China. It is also the owner and operator
of an independent reference laboratory, equivalent of a CLIA lab, in China
- Beijing BioChain Medical Laboratory (BBML).
- 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.
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02.05.2016 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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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
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459549 02.05.2016
DGAP-News: Epigenomics AG: China FDA names Epigenomics' blood-based Septin9 colorectal cancer test a most innovative medical product for 2015
| Source: EQS Group AG