DGAP-News: Epigenomics AG / Key word(s): Study/Miscellaneous
Epigenomics AG: Epigenomics' Partner BioChain Successfully Completes
Clinical Validation Study for CFDA Approval of Epi proColon(R) in
China
24.04.2014 / 12:10
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- 74.8% sensitivity and 97.4% specificity demonstrated in cohort of 1,074
patients; results in line with those achieved in the European CE
marking study reported in 2011
- BioChain filed for regulatory approval of Epi proColon(R) with the
CFDA, expecting commercialization of the test to start in 2015
Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China),
April 24, 2014 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX:
EPGNY), the German-American cancer molecular diagnostics company, and
BioChain Institute Inc. (BioChain), a leading clinical diagnostics company
in cancer and genetic tests in China and the U.S.A., today announced that
BioChain has completed its major clinical validation study to validate
Epigenomics' blood-based Septin9 screening assay Epi proColon(R) for the
early detection of colorectal cancer (CRC) with the goal to gain market
approval for the test in China. In addition, BioChain has officially
submitted an application to China Food and Drug Administration (CFDA) in
April for the approval of Epi proColon(R). Both companies expect
commercialization of the test in China to start in 2015.
The clinical validation study was designed to evaluate the clinical
performance of Epi proColon(R) for the detection of CRC and is part of the
required data package to seek regulatory approval in China. From November
2013 to March 2014, a total of 1,074 patients at three top ranking
hospitals in China were tested by using Epigenomics' Epi proColon(R) 2.0 CE
assay. Epi proColon(R) detected 74.8% of the cancer cases (sensitivity) and
correctly identified 97.4% of the patients free of disease (specificity).
The tested study cohort included 300 cancer cases in stages I to IV. The
results were marked as positive when at least two out of three samples of
the test triplicate were evaluated as positive.
The results were in line with those achieved in Epigenomics' European CE
marking study reported in 2011, which followed the same principle of data
interpretation (80% sensitivity and 99% specificity).
Grace Tian, CEO of BioChain, commented: "We are excited about the excellent
performance of Epi proColon(R) in this clinical trial. These results and
the filing for regulatory approval of Epi proColon(R) with the CFDA are
significant milestones towards commercialization of this sophisticated
cancer screening test in the Chinese market. We strongly believe that the
convenience and the simplicity of the blood-based Epi proColon(R) test will
pave the way to significantly improve CRC screening in China."
Dr. Thomas Taapken, CEO/CFO of Epigenomics, added: "We are thrilled that
BioChain completed this clinical study sooner than anticipated, which
expresses their strong commitment and enthusiasm to bring our test into the
Chinese market. CRC has a very good prognosis if detected at an early
stage. Regular screening for cancer, therefore, is highly desirable. We are
proud to contribute to implement CRC screening based on a convenient
blood-based test to reduce incidence and mortality of the disease in
China."
This was the first clinical study to demonstrate the clinical utility of
the Septin9 assay in China. In accordance with internationally accepted
guidelines, nearly 290 million people are currently eligible for CRC
screening in China and effective testing methods that are accepted by
patients are needed. CRC is a rapidly growing medical problem. In a report
published in December 2013, 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. As this is demanding for
better, simple to use and affordable screening methods, the Chinese
government has elected CRC screening as one of its key focus areas in
cancer prevention.
A successful cooperation
In March 2013, BioChain licensed Epigenomics' methylated Septin9 marker for
the blood-based detection of colorectal cancer (CRC). The collaboration was
significantly expanded in October 2013 when BioChain acquired an exclusive
license to develop and commercialize Septin9 IVD for CRC screening in the
Chinese market and took a stake in the company.
Both companies are also working together on the validation of other
methylation biomarkers in the cancer field. Epigenomics owns intellectual
property around a variety of cancer diagnostic markers for lung, prostate
and bladder cancer as well as for other solid tumors and markets a CE
marked product for lung cancer diagnosis based on its proprietary SHOX2
biomarker. BioChain's advanced sample preparation technology is a valuable
asset for the clinical validation of Epigenomics' other DNA methylation
cancer markers. Should the companies develop any future products, BioChain
shall have the option to acquire commercialization rights for the Chinese
market, while Epigenomics will retain rights for the rest of the World.
- Ends -
Contact Epigenomics AG
Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse 1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
For US press inquiries:
Epigenomics, Inc.
9700 Great Seneca Highway Rockville
Maryland 20850
pr@epigenomics.com
About Epigenomics
Epigenomics (www.epigenomics.com) is a molecular diagnostics company
developing and commercializing a pipeline of proprietary products for
cancer. The Company's products enable doctors to diagnose cancer earlier
and more accurately, leading to improved outcomes for patients.
Epigenomics' lead product, Epi proColon(R), is a blood-based test for the
early detection of colorectal cancer, which is currently marketed in Europe
and is under regulatory review by the FDA for the U.S.A. and the CFDA for
China. Additionally, the company markets its tissue assay for use in lung
cancer diagnosis, Epi proLung(R), in Europe. The Company's technology and
products have been validated through multiple partnerships with leading
global diagnostic companies and testing laboratories. Epigenomics is an
international company with operations in Europe and the U.S.A.
About BioChain
BioChain (www.biochain.com, www.biochainbj.com) is a manufacturer of Life
Sciences tools and the 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). BBML is unique in that it focuses on the application of
molecular diagnostics technologies and products. BBML is located in the
economic development zone of Beijing, China. Through BBML, BioChain is
committed to the application of the cutting edge "omics" technologies in
the areas of reproductive health and cancer diagnosis.
BBML offers comprehensive services to its customers in China with a list of
cellular and molecular test menus based on diverse technologies appropriate
to each stage and type of disease. Technology platforms employed by
BioChain include karyotyping analysis of cytogenetics, fluorescent in-situ
hybridization (FISH), array comparative genomic hybridization (aCGH),
quantitative PCR (qPCR), Sanger sequencing, next generation sequencing
(NGS), multiplex ligation-dependent probe amplification (MLPA), and genetic
linkage analysis. BioChain has a strong bioinformatics team and established
the first Chromosomal Health Database for the Chinese population
(www.szjkzd.org:8080/app/auth).
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.
The information contained in this communication does not constitute nor
imply an offer to sell or transfer any product, and no product based on
this technology is currently available for sale by Epigenomics in the
United States or Canada. The analytical and clinical performance
characteristics of any Epigenomics product based on this technology which
may be sold at some future time in the U.S. have not been established.
End of Corporate News
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Language: English
Company: Epigenomics AG
Kleine PräsidentenstraÃe 1
10178 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir@epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A1K0516
WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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264498 24.04.2014
DGAP-News: Epigenomics AG: Epigenomics' Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon(R) in China
| Source: EQS Group AG