EANS-News: Epigenomics AG Completes U.S. Clinical Validation Study for
Colorectal Cancer Blood Test Epi proColon; Provides Update on U.S. Regulatory
Plans
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Company Information/New Products/molecular diagnostics
Subtitle: Conference Call Scheduled for today, 9thDecember 2011 at 4 pm CET
Berlin, Germany, and Seattle, WA, U.S.A., December 9, 2011 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic
company, today reports the completion of the clinical validation study for its
second-generation colorectal cancer blood test Epi proColon in the U.S. The
study was designed to measure the clinical performance of Epi proColon for the
detection of colorectal cancer in comparison to colonoscopy and is part of the
required data package to seek regulatory approval of the product in the U.S. In
the reported study, Epi proColon detected 68% of the colorectal cancer cases
(sensitivity) while correctly identifying 80% of the patients free of disease
(specificity). While the results of the study represent the lower end of the
expected performance data, the findings of the study confirm the results
obtained in a previously conducted clinical study with the first generation of
the company's Epi proColon test in the same cohort of patients.
Study subjects tested were selected from a prospectively collected cohort of
7.940 individuals, defined as being at average risk for colorectal cancer by
current screening guidelines and who underwent colonoscopy for colorectal cancer
screening. The tested study cohort included 45 cancer cases. All plasma samples
selected were blinded, randomized, and tested with Epi proColon at three
independent laboratories in the U.S.
After consultation with the U.S. Food and Drug Administration (FDA), the company
confirmed that the clinical data would be assessed as part of the regular
Premarket Approval (PMA) review process. The Company will begin the regulatory
process with the FDA by submitting the first module of its PMA this month. In
addition to the clinical validation study data, Epigenomics will also perform a
head-to-head comparative study for colorectal cancer detection through
comparison with fecal immunochemical testing (FIT) for the purpose of
demonstrating non-inferiority of Epi proColon to FIT. This study will also
become an integral part of the PMA submission to the FDA and is anticipated to
be completed in 2012.
Conference Call for Investors and Media
Epigenomics' management will host a conference call to discuss the study results
and to inform about the further process of the FDA submission at 4 pm CET (10 am
EST) today, December 9, 2011. The dial-in numbers for the conference call are:
Dial-in number (within Germany): +49 69 247 501 899
Dial-in number (within U.K.): +44 203 147 4861
Dial-in number (within the US): +1 212 444 0297
Participants are kindly requested to dial in 10 minutes prior to the start of
the call.
A recording of the conference call will be provided on Epigenomics' website
subsequently: http://www.epigenomics.com/en/news-investors.html
Contact Epigenomics AG
Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.comwww.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®, is
a blood-based test for the early detection of colorectal cancer, which is
currently marketed in Europe and is in development for the U.S.A. The Company's
technology and products have been validated through multiple partnerships with
leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest
Diagnostics. Epigenomics is an international company with operations in Europe
and the U.S.A.
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.
Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
antje.zeise@epigenomics.com
end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, München
language: English