04.01.2012
Berlin, Germany, and Seattle, WA, U.S.A. - Epigenomics AG
(Frankfurt Prime Standard: ECX), the German-American
cancer molecular diagnostics company, is pleased to
announce that it has submitted the first module of its
premarket approval (PMA) submission to the US Food and
Drug Administration (FDA) on December 30, 2011.
On December 30, 2011 Epigenomics has initiated the
process of gaining US regulatory approval of its
colorectal cancer (CRC) screening test Epi proColon® by
submitting the first module of its modular PMA approval
submission to the FDA. The first module of the submission
includes all required documentation on the manufacturing
and quality controls section in relation to the product.
Further modules are scheduled to be submitted throughout
the first and second quarters of 2012 and the final
module, including all clinical data is scheduled for
submission in the second half of 2012. Under the FDA's
modular PMA submission protocol, in its guidance document
"Guidance for Industry and FDA staff - Premarket Approval
Application Modular Review", the FDA provides for a 90
day review period by the agency for each individual
module.
As previously announced, a head-to-head comparative study
with the goal of demonstrating non-inferiority of Epi
proColon® to fecal immunochemical testing (FIT) will be
an integral part of the clinical module. The design of
the clinical study has been discussed with the FDA and
upon finalizing of the study protocol, it will be
initiated in the coming months. The clinical module of
the PMA submission will encompass the results of the
head-to-head comparative study, previously announced data
from a clinical validation study in a cohort of
prospectively collected samples and other clinical study
results generated during the development of Epi
proColon®.
Geert Nygaard, CEO of Epigenomics commented: "We are
pleased that we have initiated the regulatory process for
our CRC screening test Epi proColon® with the FDA. We
intend to initiate the additional head-to-head study of
our product against FIT as soon as possible, which would
be required to meet our ambitious timeline for the
completion of our submission in the second half of
2012."
- Ends -
Further Information
Contact Epigenomics AG
Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.com
www.epigenomics.com
About Epigenomics
Epigenomics (www.epigenomics.com) is a molecular
diagnostics company developing and commercializing a
pipeline of proprietary products for cancer. The
Company's products enable doctors to diagnose cancer
earlier and more accurately, leading to improved outcomes
for patients. Epigenomics' lead product, Epi proColon®,
is a blood-based test for the early detection of
colorectal cancer, which is currently marketed in Europe
and is in development for the U.S.A. The Company's
technology and products have been validated through
multiple partnerships with leading global diagnostic
companies including Abbott, QIAGEN, Sysmex, and Quest
Diagnostics. Epigenomics is an international company with
operations in Europe and the U.S.A.
Epigenomics legal disclaimer
This communication expressly or implicitly contains
certain forward-looking statements concerning Epigenomics
AG and its business. Such statements involve certain
known and unknown risks, uncertainties and other factors
which could cause the actual results, financial
condition, performance or achievements of Epigenomics AG
to be materially different from any future results,
performance or achievements expressed or implied by such
forward-looking statements. Epigenomics AG is providing
this communication as of this date and does not undertake
to update any forward-looking statements contained herein
as a result of new information, future events or
otherwise.
The information contained in this communication does not
constitute nor imply an offer to sell or transfer any
product, and no product based on this technology is
currently available for sale by Epigenomics in the United
States or Canada. The analytical and clinical performance
characteristics of any Epigenomics product based on this
technology which may be sold at some future time in the
U.S. have not been established.
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