EANS-News: Epigenomics´ Epi proLung® BL Assay shows Strong Performance as
Confirmation Test for Lung Cancer Diagnosis
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New Products/Company Information/molecular diagnostics
Berlin, Germany, and Seattle, WA, U.S.A., February 14, 2012 (euro adhoc) -
Epigenomics AG (Frankfurt Prime Standard: ECX), the German-American cancer
molecular diagnostics company, is pleased to announce the results from a
clinical study conducted by Professor Dr. Manfred Dietel and his team from the
Institute of Pathology of the Charité University Hospital in Berlin, Germany. In
the reported study, the clinical performance of the Epi proLung® BL assay (based
on Epigenomics´ proprietary biomarker detecting methylated SHOX2) was evaluated
in bronchial washings from patients suspected of having lung carcinoma.
In the prospective study conducted between March 2011 and November 2011, a total
of 228 bronchial washing specimens were submitted to cytological analysis
according to established clinical routine. In addition, the Epi proLung® BL
assay was performed on all patient samples. Final clinical status indicated that
54 of the 228 subjects were definitively diagnosed with lung carcinoma. Of the
54 confirmed lung carcinoma subjects, 29 were detected by both tests, 12 were
detected by the Epi proLung® BL assay only, and 12 were detected by cytological
analysis only. The combination of both cytological analysis and the Epi proLung®
BL assay resulted in a final sensitivity of 98% at a specificity of 92%. Only
one confirmed lung cancer case was missed with the combined analysis.
Based on these results, which independently confirm the clinical utility of the
Epi proLung® BL assay, Charité has announced that the assay will be introduced
into its clinical practice as a routine aid in the diagnosis of lung cancer in
patients with negative or suspicious cytological results.
The results of this study will be presented by Prof. Dr. M. Dietel at the Annual
Meeting of the German Association of Pathologists end of May in Berlin.
Dr. Uwe Staub, Senior Vice President of Development and Manufacturing commented:
"These results demonstrate the power of our proprietary biomarker assay to
further aid in a definitive diagnosis for lung cancer. It is gratifying to see
the implementation of this test into a clinical routine practice, confirming our
efforts in the development of Epi proLung® BL assay".
- Ends -
Further Information
Contact Epigenomics AG
Antje Zeise
Manager IR | PR
Epigenomics AG
Tel +49 (0) 30 24345 368
ir@epigenomics.comwww.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.
Further inquiry note:
Antje Zeise | CIRO
Manager IR/PR
Epigenomics AG
Tel: +49 30 24345 386
antje.zeise@epigenomics.com
end of announcement euro adhoc
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company: Epigenomics AG
Kleine Präsidentenstraße 1
D-10178 Berlin
phone: +49 30 24345-0
FAX: +49 30 24345-555
mail: ir@epigenomics.com
WWW: http://www.epigenomics.com
sector: Biotechnology
ISIN: DE000A1K0516
indexes: Prime All Share, Technology All Share
stockmarkets: free trade: Berlin, München, Hamburg, Düsseldorf, Stuttgart,
regulated dealing/prime standard: Frankfurt
language: English