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Epigenomics AG: FDA Issues Response Letter for Epigenomics' Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval
DGAP-News: Epigenomics AG / Key word(s): Miscellaneous
Epigenomics AG: FDA Issues Response Letter for Epigenomics' Colorectal
Cancer Screening Blood Test Epi proColon(R) Requesting Further Data
Pre-Approval
02.06.2014 / 21:30
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- Meeting to discuss next steps with FDA scheduled in June
- FDA decision has no impact on commercialization of Septin9-based tests
by LDT partners or existing commercial arrangements for Epi proColon(R)
in other regions
- Company remains committed to offer highly efficient and convenient
alternative for CRC screening
Berlin (Germany) and Germantown, MD (U.S.A.), June 2, 2014 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, today announced that it has received a
response letter from the U.S. Food and Drug Administration (FDA) in
relation to its premarket approval (PMA) application for the Company's
blood-based colorectal cancer (CRC) screening test Epi proColon(R).
In its letter, the FDA determined that while the studies performed so far
have established the clinical performance characteristics of the test, the
PMA application does not yet contain sufficient evidence to warrant an
approval for Epi proColon(R). However, the FDA provided helpful guidance on
how to amend the PMA to make it approvable. The main item stressed in their
response letter revolves 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 FIT. Since Epigenomics' originally conducted clinical
studies were performed in patients who had agreed to a routine screening
colonoscopy, the FDA is requesting Epigenomics to demonstrate whether
patients in the targeted population can be turned compliant to CRC
screening by Epi proColon(R).
Epigenomics has scheduled a meeting with the FDA at the end of June in
order to discuss next steps and how to best address the outstanding
questions. It is expected that an additional study to demonstrate increased
compliance and adherence of patients to blood-based CRC testing will be
needed to address FDA's outstanding requests. Details around this study
will be determined in dialog with the FDA.
"We were surprised with FDA's assessment of our PMA submission. While this
is not what we expected, we remain fully committed to offering people who
are unwilling or unable to undergo recommended CRC screening a highly
- Meeting to discuss next steps with FDA scheduled in June
- FDA decision has no impact on commercialization of Septin9-based tests
by LDT partners or existing commercial arrangements for Epi proColon(R)
in other regions
- Company remains committed to offer highly efficient and convenient
alternative for CRC screening
Berlin (Germany) and Germantown, MD (U.S.A.), June 2, 2014 - Epigenomics AG
(Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer
molecular diagnostics company, today announced that it has received a
response letter from the U.S. Food and Drug Administration (FDA) in
relation to its premarket approval (PMA) application for the Company's
blood-based colorectal cancer (CRC) screening test Epi proColon(R).
In its letter, the FDA determined that while the studies performed so far
have established the clinical performance characteristics of the test, the
PMA application does not yet contain sufficient evidence to warrant an
approval for Epi proColon(R). However, the FDA provided helpful guidance on
how to amend the PMA to make it approvable. The main item stressed in their
response letter revolves 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 FIT. Since Epigenomics' originally conducted clinical
studies were performed in patients who had agreed to a routine screening
colonoscopy, the FDA is requesting Epigenomics to demonstrate whether
patients in the targeted population can be turned compliant to CRC
screening by Epi proColon(R).
Epigenomics has scheduled a meeting with the FDA at the end of June in
order to discuss next steps and how to best address the outstanding
questions. It is expected that an additional study to demonstrate increased
compliance and adherence of patients to blood-based CRC testing will be
needed to address FDA's outstanding requests. Details around this study
will be determined in dialog with the FDA.
"We were surprised with FDA's assessment of our PMA submission. While this
is not what we expected, we remain fully committed to offering people who
are unwilling or unable to undergo recommended CRC screening a highly
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