Epigenomics AG / Key word(s): Miscellaneous
27.03.2014 02:20
Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
by DGAP - a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
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FDA Advisory Committee votes favorably that the benefits of Epi proColon(R)
outweigh the risks
Berlin (Germany) and Germantown, MD (U.S.A.), March 27, 2014 - Epigenomics
AG (ISIN: DE000A1K0516, OTCQX: EPGNY) today announced the outcome of a
meeting of the Molecular and Clinical Genetics Panel of FDA's Medical
Devices Advisory Committee held in conjunction with its premarket approval
(PMA) for its blood-based colorectal cancer (CRC) screening test Epi
proColon(R). After deliberations, the members of the Medical Devices
Advisory Committee voted positively that the benefits of Epi proColon(R)
outweigh the risks for use in patients who meet the criteria.
In addition to reviewing the Company's clinical data and the performance of
Epi proColon(R), the advisory committee discussed data presented by the FDA
as well as testimonies shared during the public comment session. The
committee also discussed risk mitigation strategies that should be
considered in addition to the current proposed labeling. The panel voted on
three questions. The Advisory Committee members voted 9 to 0 favorably with
one abstention in assessing whether there is reasonable assurance for safe
use of the product in the intended population. The Advisory Committee
members were split 5 to 5 in the vote assessing the effectiveness for use
of the product in the intended population, with a negative vote from the
Panel Chairperson to break the tie. Finally, the panel voted on the
question of whether for patients who meet the criteria specified in the
proposed intended use, the benefits outweigh the risks for use of Epi
proColon(R). The Advisory Committee members voted 5 to 4 favorably, with
one abstention, supporting the view that the product's benefits outweigh
its risks. While recommendations of the Advisory Committee are not binding,
they will be considered in during FDA's review process.
The panel expressed concerns about the lack of long-term data in a
programmatic use of the product under the proposed intended use. As part of
the intention to establish Epi proColon(R) as a CRC screening alternative
for patients currently not compliant to existing methods such as
colonoscopy or stool-based tests, Epigenomics proposes to perform a
post-approval study. More specifically, Epigenomics intends to investigate
longitudinal performance of the test in a screening situation, in order to
assess the long-term benefits of CRC screening utilizing Epi proColon(R).
The Company believes this will address the panel's concern.
The Company will meet with the PMA review team of the FDA to discuss a
product labeling that is addressing the concerns as well as the design of
the proposed post-approval study. After this meeting, Epigenomics will
provide a detailed update about its planned next steps and expectations
around the regulatory timeline. It is currently expected that such a
meeting will be held within the next four to six weeks.
The Company had completed the PMA filing for Epi proColon(R) for US
approval with the FDA in early 2013, which was subsequently accepted and
granted priority review status by the FDA in February 2013.
The meeting of the Molecular and Clinical Genetics Panel of FDA's Medical
Devices Advisory Committee was held on March 26, 2014 in Gaithersburg, MD
and was convened by FDA as part of the PMA review process for Epi
proColon(R). Of note, this was the first time this panel was convened to
discuss a PMA. The Committee discussed and evaluated the effectiveness,
safety, and the benefit-risk profile of Epi proColon(R) in order to make
appropriate recommendations regarding the safe and effective use of the
test to FDA.
- End of Ad hoc -
Contact Epigenomics AG
Antje Zeise CIRO
Manager IR | PR
Epigenomics AG
Phone: +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com
Epigenomics' legal disclaimers. 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.
27.03.2014 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: Epigenomics AG
Kleine Präsidentenstraße 1
10178 Berlin
Germany
Phone: +49 30 24345-0
Fax: +49 30 24345-555
E-mail: ir@epigenomics.com
Internet: www.epigenomics.com
ISIN: DE000A1K0516
WKN: A1K051
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of Announcement DGAP News-Service
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27. March 2014 - 0:00 (CEST)