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| Ad Hoc Announcement pursuant of §15 WpHG (German Securities Trading Act): Epigenomics AG: Strategic Partner Abbott Launches Colorectal Cancer Blood Test in Europe and Asia/Pacific |
Monday, 21.12.2009 |
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| Epigenomics AG: PRESEPT Study Subject Enrollment Successfully Completed |
Thursday, 17.12.2009 |
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7,852 subjects prospectively enrolled including more than 50 cancer cases
Blood samples selected for testing by independent biostatistics group
Septin9 testing in three independent laboratories on track; majority of samples tested
Completion of PRESEPT Study and reporting of top-line results expected for early 2010
Press release, Berlin, Germany, and Seattle, WA, U.S.A. |
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| Epigenomics AG Reports Q3 and Nine Months 2009 Results |
Tuesday, 10.11.2009 |
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Key Figures 9M 2009
Revenue, EBIT and net loss significantly improved
• Revenue: EUR 3.2 million in 9M 2009, up by 77% (9M 2008: EUR 1.8 million)
• EBIT: EUR – 7.1 million in 9M 2009, improved by 17% (9M 2008: EUR –8.5 million)
• Net loss: EUR – 7.1 million in 9M 2009, decreased by 13% (9M 2008: EUR –8.1 million)
• Liquid assets: EUR 9.5 million at end of September 2009 (31/12/2008: EUR 12.1 million)
Operational Highlights Fiscal Year (FY) 2009 to Date
• Launched Epi proColon, the first CE-marked IVD kit for colorectal cancer blood testing
• Colorectal cancer blood test available to patients through Swiss diagnostic laboratory Viollier AG and four German laboratories
• Progressed PRESEPT colorectal cancer clinical study
• Development of Abbott Septin9 product on track for European launch in Q4/ 2009
• Signed licensing deal with ARUP Laboratories for non-exclusive U.S. rights to mSEPT9 for laboratory-developed test (LDT) use
• Finalized clinical evaluation of mSHOX2 lung cancer biomarker and initiated product development
• Strengthened intellectual property position by cross license with DxS Ltd., since then acquired by Qiagen
Epigenomics to present today at investor conference at the German Equity Forum of the Deutsche Börse Group in Frankfurt/ Main, Germany
Press release, Berlin, Germany, and Seattle, WA, U.S.A., November 10, 2009
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| Epigenomics AG: U.S. Development Partner Quest Diagnostics Completes Clinical Development of Septin9 Colorectal Cancer Blood Test |
Monday, 02.11.2009 |
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| Press release, Berlin, Germany, and Seattle, WA, USA |
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| Epigenomics AG Initiates Testing of Blood Plasma Samples from PRESEPT Study in Three Independent Clinical Laboratories |
Thursday, 08.10.2009 |
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PRESEPT Study evaluates clinical performance and health economic benefit of colorectal cancer screening with mSEPT9 blood test
Quest Diagnostics, ARUP Laboratories, and Charité - Universitätsmedizin Berlin selected to test mSEPT9 biomarker in blood plasma samples from PRESEPT Study subjects
Laboratories to use recently launched Epi proColon CE Marked IVD test products for the testing of the PRESEPT medical research study samples
Selection of about 1,500 masked blood samples to be tested in several batches - data analysis after last sample of last batch is tested
PRESEPT enrollment now exceeds 6,400 subjects with more than three quarters of targeted 50 colorectal cancer cases accrued
Laboratories to start testing in October – completion expected late 2009 or early 2010
Press release, Berlin, Germany, and Seattle, WA, USA |
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| Epigenomics AG Launches its Epi proColon Product in Europe - the First Ever In Vitro Diagnostic Blood Test for Colorectal Cancer Early Detection |
Tuesday, 06.10.2009 |
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Epi proColon is the first CE-marked test in accordance with European IVD regulations for the early detection of colorectal cancer in a simple blood draw
Epi proColon finds two thirds of cancers at early, curable disease stages in final performance evaluation study
Epi proColon will now be made available to molecular diagnostics laboratories, patients, and doctors in Europe
Epigenomics to commercialize Epi proColon through direct marketing and sales in Germany, Switzerland, Austria and via distributors in the rest of Europe
Epigenomics commercial strategy evolves to a dual business model combining direct commercialization and non-exclusive licensing partnerships
Press release, Berlin, Germany, and Seattle, WA, USA, |
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| Ad Hoc Announcement pursuant of §15 WpHG (German Securities Trading Act): Epigenomics AG Launches Colorectal Cancer Blood Test Epi proColon in Europe |
Tuesday, 06.10.2009 |
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| Epigenomics AG: First Blood Test for Colorectal Cancer Available in Germany |
Monday, 21.09.2009 |
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First diagnostic laboratories start offering testing based on Epigenomics’ Septin9 biomarker on October 1st
Test is able to detect colorectal cancer in a simple blood draw
Company hosts press conference at ECCO/ESMO Congress in Berlin today
Press release, Berlin, Germany, and Seattle, WA, U.S.A. |
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| Epigenomics AG: Clinical Study Shows Lead Biomarker for Lung Cancer also works in Blood |
Tuesday, 25.08.2009 |
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Biomarker mSHOX2 could accelerate diagnostic work-up of patients with suspected lung cancer
Press release, Berlin, Germany, and Seattle, WA, USA |
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| Ad hoc (§15 WpHG): Epigenomics AG Licenses Biomarker for Colorectal Cancer Blood Test to ARUP Laboratories, Inc. |
Wednesday, 12.08.2009 |
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Ad Hoc Announcement pursuant of §15 WpHG
(German Securities Trading Act)
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| Epigenomics AG Licenses Biomarker for Colorectal Cancer Blood Test to ARUP Laboratories |
Wednesday, 12.08.2009 |
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ARUP to commercialize laboratory-developed blood test based on Epigenomics’ mSEPT9 biomarker to aid in the early detection of colorectal cancer
Press Release, Berlin, Germany, and Seattle, WA, U.S.A. |
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| Epigenomics AG Reports First Half 2009 Results |
Tuesday, 11.08.2009 |
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Key Figures
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Revenue: EUR 2.1 million in H1 2009, up by 37% (H1 2008: EUR 1.5 million)
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EBIT: EUR – 4.8 million in H1 2009, improved by 19% (H1 2008: EUR –5.9 million)
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Net loss: EUR – 4.8 million in H1 2009, decreased by 15% (H1 2008: EUR –5.6 million)
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Liquid assets: EUR 12.1 million as of 30/06/2009 (31/12/2008: EUR 12.1 million)
Highlights of the First Half 2009
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Significantly improved revenue, EBIT and net loss
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Progressed PRESEPT colorectal cancer clinical study according to plan
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First diagnostic mSEPT9 blood testing service for colorectal cancer launched by Swiss Viollier AG
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Development of Abbott mSEPT9 IVD product on track for European product launch in Q4/2009
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Awarded grant by the German Federal Government for further research into colorectal cancer biomarkers
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Presented mSEPT9 data and reported on progress of PRESEPT Study at several international conferences
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Received allowances for key patents in Europe
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Obtained ISO 13485 certification for development, manufacturing and distribution of IVD products. |
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| DxS and Epigenomics Cross-License Technology for In Vitro Diagnostics |
Monday, 20.07.2009 |
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| Both companies to use Scorpions® technology for diagnostic products based on DNA methylation |
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| Epigenomics AG Certified for Diagnostic Product Development and Commercialization |
Tuesday, 30.06.2009 |
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ISO 13485 certification marks a milestone in Epigenomics’ commercial strategy
Press release, Berlin, Germany, and Seattle, WA, USA, |
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| Epigenomics AG Presents Colorectal Cancer Blood Test at ESMO Conference |
Thursday, 25.06.2009 |
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mSEPT9 biomarker facilitates innovative blood test for colorectal cancer
PRESEPT Study for colorectal cancer screening with mSEPT9 well on track
First European diagnostic laboratory to offer mSEPT9 testing on 1st July
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| Swiss Viollier AG First Laboratory in Europe to offer Epigenomics' Colorectal Cancer Blood Test |
Tuesday, 23.06.2009 |
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The Swiss private diagnostic laboratory will launch mSEPT9 blood testing service for colorectal cancer early detection on July 1, 2009
Press release, Berlin, Germany, and Seattle, WA, USA, |
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| Epigenomics AG reports progress in clinical development of its colorectal cancer blood test during Digestive Disease Week |
Tuesday, 02.06.2009 |
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mSEPT9 biomarker facilitates innovative blood test for colorectal cancer
mSEPT9 data published in Clinical Chemistry
PRESEPT Study for colorectal cancer screening with mSEPT9 well on track
Press release, Berlin, Germany, and Seattle, WA, USA |
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| Epigenomics AG Presents Clinical Data from Prostate Cancer Prognosis Study at ASCO |
Friday, 29.05.2009 |
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Biomarker mPITX2 for prostate cancer prognostic application successfully validated
First clinical laboratory in Germany to start offering mPITX2 testing service
Press release, Berlin, Germany, and Seattle, WA, USA |
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| Novel German Research Alliance to Detect Precursors of Colorectal Cancer - Munich Technical University, Epigenomics AG and KVB to develop novel approaches to cancer prevention |
Tuesday, 26.05.2009 |
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| Press release, Berlin and Munich, Germany, |
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| Epigenomics AG Receives Allowances for Key Patents in Europe |
Wednesday, 13.05.2009 |
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Patents cover biomarker mPITX2 for prostate and breast cancer indications
Press release, Berlin, Germany, and Seattle, WA, USA |
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| Epigenomics AG Reports First Quarter 2009 Financial Results |
Monday, 11.05.2009 |
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Key Figures
- Revenue: EUR 1.24 million in Q1 2009, up by 36% (Q1 2008: EUR 0.92 million)
- EBIT: EUR -2.31 million in Q1 2009, improved by 22% (Q1 2008: EUR –2.95 million)
- Net loss: EUR -2.42 million in Q1 2009, decreased by 16% (Q1 2008: EUR -2.87 million)
- Liquid assets: Strengthened at EUR 14.98 million as of 31/03/2009 (31/12/2008: EUR 12.10 million
Highlights of the First Quarter 2009
- All key financials improved
- PIPE placement secures funding towards end of 2010
- Development of mSEPT9 colorectal cancer blood test by Abbott Molecular on track for Q4-2009 product launch in Europe
- Progressed PRESEPT colorectal cancer clinical study according to plan
- Signed mSEPT9 colorectal cancer blood test R&D collaboration with Sysmex
- Expanded Quest Diagnostics licensing deal to include mGSTP1 for prostate cancer
- Executed mGSTP1 licensing deal with Predictive Bioscience
- Successfully completed clinical evaluation of mSHOX2 lung cancer biomarker and initiated product development
- Initiated “Early Access Program” for mPITX2 prostate cancer prognostic test in Europe
Press Release, Berlin, Germany and Seattle, WA, U.S.A.,
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| Epigenomics AG Licenses Biomarker for Development of Prostate Cancer Test to Predictive Biosciences |
Tuesday, 28.04.2009 |
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Press Release, Berlin, Germany and Seattle, WA, U.S.A.,
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| Epigenomics AG Reports Financial Results for the Fiscal Year 2008 |
Tuesday, 31.03.2009 |
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Please note that the dial-in details changed for today´s conference call.
Successfully delivering on new partnering deals - PRESEPT clinical trial on track – Product launches expected in 2009 - Financials in line with latest expectations – Two successful financing transactions
Press Release, Berlin, Germany and Seattle, WA, USA, |
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| Ad hoc (§15 WpHG): Epigenomics AG: Notice of Loss |
Wednesday, 25.03.2009 |
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| Berlin, Germany, |
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| Epigenomics AG Moves Lung Cancer Test into Development after Successful Clinical Evaluation |
Wednesday, 18.03.2009 |
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Test to aid in the diagnosis of lung cancer after positive CT findings
Berlin, Germany and Seattle, WA, U.S.A., |
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| Epigenomics AG Licenses Biomarker for Development of Prostate Cancer Test to Quest Diagnostics |
Wednesday, 25.02.2009 |
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| Press release, Berlin, Germany, and Seattle, WA, U.S.A. |
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| Epigenomics AG Successfully Places Shares at Premium in Capital Increase |
Thursday, 12.02.2009 |
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Press Release
Berlin, Germany and Seattle, WA. U.S.A. |
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| Ad Hoc (§15 WpHG): Epigenomics AG Increases Share Capital |
Wednesday, 11.02.2009 |
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Ad Hoc Announcement persuant of §15 WpHG
(German Securities Trading Act)
Berlin, Germany |
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| Ad hoc Announcement According to §15 WpHG (German Securities Trading Act): Epigenomics AG Signs Strategic R&D Collaboration Agreement in Colorectal Cancer with Sysmex Corporation |
Thursday, 22.01.2009 |
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| Berlin, Germany |
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| Sysmex and Epigenomics AG Announce Strategic R&D Collaboration in Colorectal Cancer Diagnostics |
Thursday, 22.01.2009 |
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- Focus on detection of methylated DNA in blood using Sysmex instrumentation
- Sysmex assay system to be benchmarked against Epigenomics’ mSEPT9 assay
- Parties entered into negotiations for a non-exclusive IVD license to mSEPT9 colorectal cancer blood test
Berlin, Germany, and Kobe, Japan
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