DGAP-News

Epigenomics AG: Epigenomics AG Announces H1 2014 and Q2 2014 Financial Results and Reports on Operational Highlights - Seite 3

the clinical performance characteristics of the test, the PMA
application does not yet contain sufficient evidence to warrant an
approval for Epi proColon(R). The main item stressed revolved around
the need for additional data demonstrating that the blood-based Epi
proColon(R) test will increase compliance to CRC screening in the
intended use population, i.e. in those patients who today do not
undergo CRC screening by guideline-recommended methods such as
colonoscopy or stool-based fecal immunochemical tests (FIT). However,
the FDA provided helpful guidance on how to amend the PMA to make it
approvable.

- Additional Study to Demonstrate Increased Compliance and Adherence
Requested: The trial is intended to be conducted in a population that
is non-compliant to CRC screening according to current screening
guidelines and may include patients actively managed by CRC screening
programs within healthcare systems. The Company already started
discussions with several healthcare organizations to participate in
such a study. The Company foresees that conducting the study can likely
be done with a reasonable number of patients that could be enrolled
within a few months. Considering the time needed to allocate for the
study initiation and logistics, the Company is aiming to submit study
data to complete the PMA application before the end of this year or
shortly thereafter.

- Results of two Major Studies with Epi proColon(R) Published in Renowned
Scientific Journals: The results from the U.S. clinical validation
study for Epi proColon(R) as well as from its head-to-head comparative
study with FIT have been published in two renowned scientific peer
reviewed journals, Clinical Chemistry (www.clinchem.org) and PLOS ONE
(www.plosone.org). This is of particular importance as payors,
policymakers, medical societies and guideline bodies will rely on this
information for their decision-making processes.

- Chinese Partner BioChain Filed Epi proColon(R) for Approval in China
Sooner than Anticipated: BioChain, a leading clinical diagnostics
company in cancer and genetic tests in China and the U.S.A., has
completed a major clinical validation study with Epi proColon(R). The
results, confirming the excellent clinical performance of the test, and
the filing for regulatory approval of Epi proColon(R) with the CFDA are
significant milestones towards commercialization of this sophisticated
CRC screening test also in the Chinese market.