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Epigenomics AG: Epigenomics Provides Corporate Update
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Epigenomics AG: Epigenomics Provides Corporate Update
01.10.2014 / 14:00
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Epigenomics Provides Corporate Update
Berlin (Germany) and Germantown, MD (U.S.A.), October 1, 2014 - Epigenomics
AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American
cancer molecular diagnostics company, today provides a corporate update on
major developments.
Epigenomics, in consultations with the U.S. Food and Drug Administration
(FDA), has completed the design of the ADMIT (Adherence to Minimally
Invasive Testing) study, which aims to demonstrate that Epi proColon(R)
will increase participation in colorectal cancer (CRC) screening in
patients being offered this convenient blood-based test as compared to
those being offered a fecal immunochemical test (FIT). The study was
requested as part of the FDA response letter on June 2, 2014 in relation to
Epigenomics' PMA submission for the Company's CRC screening test. It will
be conducted in average risk, screening eligible patients that have been
historically non-compliant to CRC screening according to current
guidelines. Once enrolled, patients will be randomized equally into two
arms to be offered either the FIT stool test kit for home use or a blood
draw for the Epi proColon(R) test. The rates of adherence between each arm
will be measured and the primary objective of the study will be to show
increased adherence for Epi proColon(R). The study's secondary endpoint is
a measurement of compliance to colonoscopy in those patients with positive
test results with Epi proColon(R) or FIT. For the identification of
appropriate patients Epigenomics will be working with two major US health
care systems, who actively manage CRC screening programs. Based on initial
estimates, the Company expects the trial to be enrolled within a few months
and costs for the study are projected to be less than EUR 1.0 million.
In parallel, Epigenomics is working closely with its partner BioChain
towards the approval of Epi proColon(R) in China, where CRC is a rapidly
growing problem also. Epigenomics has supported the data generation and
technical documentation efforts of BioChain throughout the approval
process, which was initiated in April of this year. Additionally, clinical
data generated in China have confirmed the performance of the Epi
proColon(R) test in the Chinese population. These data were included in the
formal submission to the China Food and Drug Administration (CFDA). Based
Berlin (Germany) and Germantown, MD (U.S.A.), October 1, 2014 - Epigenomics
AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American
cancer molecular diagnostics company, today provides a corporate update on
major developments.
Epigenomics, in consultations with the U.S. Food and Drug Administration
(FDA), has completed the design of the ADMIT (Adherence to Minimally
Invasive Testing) study, which aims to demonstrate that Epi proColon(R)
will increase participation in colorectal cancer (CRC) screening in
patients being offered this convenient blood-based test as compared to
those being offered a fecal immunochemical test (FIT). The study was
requested as part of the FDA response letter on June 2, 2014 in relation to
Epigenomics' PMA submission for the Company's CRC screening test. It will
be conducted in average risk, screening eligible patients that have been
historically non-compliant to CRC screening according to current
guidelines. Once enrolled, patients will be randomized equally into two
arms to be offered either the FIT stool test kit for home use or a blood
draw for the Epi proColon(R) test. The rates of adherence between each arm
will be measured and the primary objective of the study will be to show
increased adherence for Epi proColon(R). The study's secondary endpoint is
a measurement of compliance to colonoscopy in those patients with positive
test results with Epi proColon(R) or FIT. For the identification of
appropriate patients Epigenomics will be working with two major US health
care systems, who actively manage CRC screening programs. Based on initial
estimates, the Company expects the trial to be enrolled within a few months
and costs for the study are projected to be less than EUR 1.0 million.
In parallel, Epigenomics is working closely with its partner BioChain
towards the approval of Epi proColon(R) in China, where CRC is a rapidly
growing problem also. Epigenomics has supported the data generation and
technical documentation efforts of BioChain throughout the approval
process, which was initiated in April of this year. Additionally, clinical
data generated in China have confirmed the performance of the Epi
proColon(R) test in the Chinese population. These data were included in the
formal submission to the China Food and Drug Administration (CFDA). Based
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