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epigenomics ag (ECX) Snapshot

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03/21/14 - €8.87
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epigenomics ag (ECX) Details

Epigenomics AG, a molecular diagnostics company, is engaged in developing and commercializing in vitro diagnostic tests for the screening and diagnosis of cancer primarily in Europe, North America, and Asia. Its lead product is Epi proColon, a blood-based test for the early detection of colorectal cancer, which relies on its proprietary DNA methylation biomarker, Septin9. The company also offers Epi proLung BL Assay, a confirmatory test that aids in the diagnosis of lung cancer. It also has development pipeline that contains tests for screening, monitoring, diagnosis, and prognosis assessment in colorectal, lung and prostate cancer. The company has license agreements with Abbott Molecular Diagnostics, Inc.; Quest Diagnostics, Inc.; ARUP Laboratories, Inc.; Gamma Dynacare; BioChain Institute, Inc.; and Companion Dx Reference Lab. The company offers its products directly, as well as through partners and distributors. Epigenomics AG was founded in 1998 and is headquartered in Berlin, Germany.

38 Employees
Last Reported Date: 10/31/14
Founded in 1998

epigenomics ag (ECX) Top Compensated Officers

Chief Executive Officer, Chief Financial Offi...
Total Annual Compensation: €288.8K
Chief Operating Officer and Member of Executi...
Total Annual Compensation: €177.2K
Compensation as of Fiscal Year 2013.

epigenomics ag (ECX) Key Developments

Epigenomics AG Announces First Patients Enrollment in ADMIT Trial

Epigenomics AG announced that first patients have been enrolled into its ADMIT trial (ADherence to Minimally Invasive Testing) for its noninvasive blood-based test for colorectal cancer (CRC) screening, Epi proColon. The trial, which was requested by the US Food and Drug Administration (FDA) in the context of Epigenomics' pre-market approval (PMA) application for Epi proColon, will be conducted in 420 patients that have been historically non-compliant to CRC screening according to current screening guidelines. Patients will be invited to a clinic visit and once enrolled into the trial, they will be randomized to either the FIT test to take home to complete and send back or to a blood draw for completion of the Epi proColon test. The primary endpoint aims to show a statistically significant increase in CRC screening participation by the patients in the trial as measured by the completion rate of either test. The study's secondary objectives will comprise a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon or FIT. Based on initial estimates, the company expects the trial to be enrolled within a few months.

Epigenomics AG Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015

Epigenomics AG Presents at The Trout Group 's Annual 1x1 Management Access Event, Jan-12-2015 . Venue: The Handlery Hotel, 351 Geary Street, Union Square, San Francisco, California, United States.

Epigenomics AG and BioChain Announce Approval of Epi proColon in China

Epigenomics AG announced that the China Food and Drug Administration (CFDA) approved Epi proColon(R) for commercialization in China. Epi proColon(R) is Epigenomics' non-invasive blood-based diagnostic test for colorectal cancer (CRC) detection based on the Septin9 DNA methylation marker. The approval was based on a major clinical validation study completed by BioChain in April 2014, which confirmed the previously demonstrated positive clinical performance of Epi proColon(R). While detecting 75% of all cancer cases at 97.5% specificity in the Chinese study, this test has the potential to become an important tool for medical professionals in establishing and expanding CRC detection in this country. The availability of CRC screening based on a blood sample will enable higher patient participation in detection of CRC as a means to reduce later stage disease and the associated costs. Epigenomics' partner in China, BioChain, expects to launch the product within the next weeks into the Chinese market through their established distribution channels and is currently preparing its market launch throughout the country.


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