EANS-News: Epigenomics AG / Epigenomics Provides Additional Data on the Outcome of its Head-to-Head Comparison Study of Epi proColon® to FIT

Geschrieben am 19-12-2012

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

Research & Development/molecular diagnostics

Berlin, Germany, and Seattle, WA, U.S.A. (euro adhoc) - Epigenomics
AG (Frankfurt Prime Standard: ECX), the German-American cancer
molecular diagnostics company, today provided detailed results from a
head-to-head comparative study between its blood-based colorectal
cancer (CRC) detection test Epi proColon® and fecal immunochemical
testing (FIT) for which it recently reported top-line results. This
trial was designed to evaluate non-inferiority of the blood based Epi
proColon® assay performance in comparison to FIT.

The subjects included in the first arm of the study were average
risk, asymptomatic screening patients with no history (own or
familial) of CRC. These patients were identified as CRC patients in
the context of screening colonoscopies performed from April-November
2012 across 70 sites in the US.

As previously reported, in this study, Epi proColon® was able to
detect 73 out of 103 cancer cases, demonstrating an overall
sensitivity of 71%. Clinical staging information of the disease was
available for 71 of the 103 cases.

Further analysis of the data shows that Epi proColon® was able to
demonstrate 61% sensitivity for 23 cases in stages 0 and 1 (FIT 61%
sensitivity), 75% for 16 cases in stage 2 (FIT 75% sensitivity), 70%
for 20 cases in stage 3 (FIT 85% sensitivity) and 92% in 12 stage 4
cases (FIT 64% sensitivity). In the 32 cases of unknown clinical
staging, the sensitivity was 69% (57% sensitivity for FIT). The
correspondence of the blood and stool based test methods was 62%,
whereby Epi proColon® was able to identify 20 cases that could not be
identified by FIT, while FIT identified 17 CRC cases, which were not
found through Epi proColon®.

The second arm of the study comprised 198 average risk individuals,
which were prospectively enrolled (i.e. before colonoscopy). Among
these, 3 CRC cases were identified by colonoscopy. Both, Epi
proColon® and FIT were able to find 2 out of these three CRC cases.
At the same time, of the 24 advanced adenomas included in the second
arm, neither method detected a significant number of these. The
adenoma detection for Epi proColon®, as shown in previous studies,
was low. Surprisingly, the finding was the same for FIT, although it
was previously believed to be a distinct advantage of this method.

Overall reported specificities for Epi proColon® and FIT were at 81%
and 98% respectively. While the point estimate of 81% specificity for
Epi proColon® was still above the pre-defined non-inferiority margin,
this result was statistically non-significant. The difference in
specificity is less vital in the Company's opinion, as patients will
undergo a colonoscopy - the currently recommended screening procedure
- as a result of a positive test result. In addition to this it is
noteworthy that the Company's CE marked version of the product,
optimized for specificity and launched in Europe earlier this year,
has a specificity for CRC detection of 99%. This could open
additional possibilities to address the US market in the future.

- Ends -

Contact Epigenomics AG

Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368

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


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