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Epigenomics AG: Epigenomics AG Announces Publication of Results of Two U.S. Clinical Studies with its Blood-based Epi proColon(R) CRC Screening Test

DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
Epigenomics AG: Epigenomics AG Announces Publication of Results of Two
U.S. Clinical Studies with its Blood-based Epi proColon(R) CRC
Screening Test

24.06.2014 / 09:00

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Berlin (Germany), Germantown, MD (U.S.A.), June 24, 2014 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, today announced that results from its U.S.
clinical validation study for its blood-based colorectal cancer (CRC)
detection test Epi proColon(R) as well as from its head-to-head comparative
study with fecal immunochemical occult blood testing (FIT) have been
published in renowned scientific journals. Both clinical studies are part
of the required data package to seek regulatory approval of Epi proColon(R)
in the U.S.

The peer-reviewed article, "Validation of a Real-Time PCR-Based Qualitative
Assay for the Detection of Methylated Sept9 DNA in Human Plasma",
discussing the data of Epigenomics' U.S. pivotal clinical validation study
has been published online on Clinical Chemistry (www.clinchem.org) and will
subsequently appear in the journal's print issue.

Based on prospectively collected plasma samples from a cohort of
approximately 8,000 average risk individuals, the study was designed to
measure the clinical performance of Epi proColon(R) for the detection of
CRC in comparison to colonoscopy. The data published in Clinical Chemistry
elaborates on top-line data Epigenomics announced in December 2011. In this
clinical study Epi proColon(R) detected 68% of colorectal cancer cases
(sensitivity) while correctly identifying 80% of the patients free of
disease (specificity). The study results establish the clinical performance
of Epi proColon(R) and suggest that under the assumption that choice drives
improvement in CRC screening participation, this novel test has the
potential to reach the otherwise non-compliant patients.

In addition, the peer-reviewed publication, "Plasma Septin9 versus Fecal
Immunochemical Testing for Colorectal Cancer Screening: A Prospective
Multicenter Study", discussing the top-line data of the head-to-head
comparative study of Epi proColon(R) versus FIT has recently been published
online on PLOS ONE (www.plosone.org).

The study was designed to demonstrate the non-inferiority of Epi
proColon(R) in detection of CRC in comparison to one of the most commonly
used FIT products in the U.S. market and was performed at 61 clinical sites
across the U.S. The published data elaborate on the top-line data
Epigenomics announced in December 2012. Sensitivity of Epi proColon(R) in