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Epigenomics AG: Epigenomics AG Reports Results for the Financial Year Ended December 31, 2014 and Provides Outlook for 2015 - Seite 4
consequence, during the second half of 2014 Epigenomics worked closely
with the agency to complete the design of the requested ADMIT trial
(ADherence to Minimally Invasive Testing).
- Enrollment into the ADMIT trial completed (after period-end); results
expected Q2 2015: In December 2014, the Company started the ADMIT trial
which was conducted in patients that have been historically
non-compliant to CRC screening according to current screening
guidelines. Subjects were invited to a clinic visit and once enrolled
into the trial, were randomized to either the FIT test to take home to
complete and send back within six weeks, or to a blood draw for the Epi
proColon(R) test, to be completed in the same time frame. The primary
endpoint is a statistically significant increase in adherence to
testing by subjects offered the Epi proColon(R) test compared to
subjects given the FIT test. The study's secondary objectives include a
measurement of compliance to colonoscopy in subjects with positive
result for either test. Subject enrollment has now been completed and
trial results will be submitted to the FDA following data analysis
after completion of the six week response window. Results are expected
to be announced during the second quarter 2015.
- Polymedco reiterated commitment to support Epi proColon(R) in the U.S.:
Epigenomics' partner Polymedco, reiterated its commitment to support
the launch and commercialization of the test in the United States.
While the ADMIT trial was underway, Polymedco continued to diligently
prepare for commercializing Epi proColon(R) once the product is
approved and has therefore commenced training its sales staff as well
as establishing customer and technical support functions. In addition,
Polymedco strongly supported Epigenomics with continued logistics and
personnel assistance in the ADMIT trial. This strong support was
further underpinned by the commitment of Polymedco's President and CEO,
Drew Cervasio, who, with a significant personal investment, has notably
increased his ownership of Epigenomics to approximately 180,000 shares.
- Epi proColon(R) approved in China: In December 2014, together with its
partner BioChain, Epigenomics received marketing approval for Epi
proColon(R) from the China Food and Drug Administration (CFDA). The
approval was based on a major clinical validation study completed by
BioChain in April 2014, which demonstrated the potential for Epi
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