Epigenomics AG

EANS-News: Epigenomics AG
Epigenomics AG Reports Non-Inferiority of Blood-based Epi proColon® against Fecal Immunochemical Testing in Detection of Colorectal Cancer in a Head-to-Head Comparative Study


--------------------------------------------------------------------------------
  Corporate news transmitted by euro adhoc. The issuer/originator is solely
  responsible for the content of this announcement.
--------------------------------------------------------------------------------

Research & Development/Research & Development/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Press release

Epigenomics AG Reports Non-Inferiority of Blood-based Epi proColon® against
Fecal Immunochemical Testing in Detection of Colorectal Cancer in a Head-to-Head
Comparative Study 

Berlin, Germany, and Seattle, WA, U.S.A., December 04, 2012 - Epigenomics AG
(Frankfurt Prime Standard: ECX), the German-American cancer molecular
diagnostics company, today announced top-line results from a head-to-head
comparative study between its blood-based colorectal cancer (CRC) detection test
Epi proColon® and fecal immunochemical testing (FIT) to demonstrate the
non-inferiority of Epi proColon® in detection of CRC.

Dr. Thomas Taapken, Chief Financial Officer and acting Chief Executive Officer
of Epigenomics, commented: "Based on the achieved non-inferiority in CRC
detection, we believe that Epi proColon® has demonstrated its value to be a
convenient non-invasive test alternative for CRC detection. Bringing a
blood-based non-invasive product like Epi proColon® to the market will
significantly drive awareness for colorectal cancer screening among individuals
that would otherwise be noncompliant, since current compliance to FIT testing
remains at low levels." 

In the reported trial, Epi proColon® detected 73 in a total of 103 evaluable
samples from patients with colorectal cancer, which represents a sensitivity of
71%. The FIT comparator used in the study, one of the most commonly used FIT
products in the US market, detected 66 out of 98 cancer cases for which stool
samples were provided, translating into a sensitivity of 67%. Based on
Epigenomics' analysis of the data, which was confirmed by an external party, the
Company met the critically important endpoint of non-inferiority with respect to
sensitivity of Epi proColon® to FIT. These results represent an important
milestone for Epigenomics and will be part of the final module of the Premarket
Approval (PMA) submission expected to be filed with the U.S. Food and Drug
Administration (FDA) before the end of this year. 

The double blind study was performed at 70 clinical trial sites across the US
and comprised two arms. The first arm included a total of 103 asymptomatic,
average risk individuals without family history or previous incidences of CRC,
who were diagnosed and confirmed as having colorectal cancer during a screening
colonoscopy. Matched blood and stool samples from these patients were collected
at least 10 days after colonoscopy but before surgical intervention. The second
arm of the study included 198 individuals selected according to the same
criteria, but whose blood and stool samples were collected before the
colonoscopy. This study arm included three cancer cases as well as advanced
adenomas, polyps and individuals with no evidence of disease. Based on all
non-CRC samples from the second arm, specificity for Epi proColon® was
determined at 81% and for FIT at 98%. These findings are in line both with
previous studies on Epi proColon® and published data for FIT. In summary,
Epigenomics met the critically important sensitivity endpoint, which provides
the potential to discover more CRC patients. The difference in specificity was
anticipated and in the Company's opinion is less vital, since patients will
undergo a colonoscopy -the currently recommended screening procedure- as a
result of a positive test result. Testing of all samples was performed strictly
according to the instructions for use by the respective manufacturers of both
tests at an independent third party testing laboratory in the US, which was
blinded to the samples analyzed.

Dr. Uwe Staub, Chief Operating Officer of Epigenomics, commented: "These
positive study results confirm the performance of our assay and indicate that
Epi proColon® is non-inferior to FIT in the detection of CRC. We look forward to
an active dialogue with the agency upon completion of our PMA filing before the
end of this year."

The company plans to submit detailed study results for presentation at a medical
meeting and for peer-reviewed publications in the near future.

Conference call for press and analysts 

Epigenomics' management will host a conference call and an audio webcast at 5pm
CET/11am ET today, Tuesday 4th December 2012. 

The dial-in numbers for the conference call are:
Dial-in number (within Germany): + 49 69 247501899 

Dial-in number (within the UK): + 44 203 1474861

Dial-in number (within the U.S.): + 1 212 4440297

Participants are kindly requested to dial in 10 minutes prior to the start of
the call. 

The presentation accompanying the conference call and dial-in details for the
audio webcast will be available on Epigenomics' website: 
{http://www.epigenomics.com/en/news-investors.html}[HYPERLINK:
http://www.epigenomics.com/en/news-investors.html] 

A webcast of the conference call will be provided on Epigenomics' website
subsequently: {http://www.epigenomics.com/en/news-investors.html}[HYPERLINK:
http://www.epigenomics.com/en/news-investors.html]
- Ends -

Contact Epigenomics AG

Antje Zeise
Manager IR | PR  
Epigenomics AG 
Tel +49 (0) 30 24345 368 
ir@epigenomics.com  
www.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

end of announcement                               euro adhoc 
--------------------------------------------------------------------------------


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: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
             regulated dealing/prime standard: Frankfurt 
language:   English
 

 

 



Das könnte Sie auch interessieren: