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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.

34 Employees
Last Reported Date: 02/25/14
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 Reports Earnings Results for the Second Quarter and first half Ended June 30, 2014; Provides Earnings Guidance for the Year 2014

Epigenomics AG reported earnings results for the second quarter and first half ended June 30, 2014. For the quarter, the company’s total revenue was up 18% to EUR 0.405 million compared to EUR 0.343 million a year ago. LBIT was EUR 1.6 million and nearly unchanged to second quarter of 2013. Net loss amounted to EUR 1.8 million compared to EUR 1.6 million last year. Net loss per share dropped slightly to EUR 0.13 from EUR 0.14 in second quarter of 2013. For the first half, the company’s revenue increased by 16% to EUR 0.812 million compared to EUR 0.698 million last year. LBIT amounted to EUR 3.6 million compared to EUR 3.3 million last year. Net loss amounted to EUR 4.1 million compared to net profit of EUR 3.4 million last year. Net loss per share increased only marginally to EUR 0.30 in first half of 2014 from EUR 0.29 in first half of 2013. Cash outflow from operating activities was EUR 3.1 million in first half of - a decrease of EUR 0.7 million compared to first half of 2013 i.e. EUR 3.8 million which was mainly attributable to the changes in current and non-current liabilities from operations. For the year 2014, the company expects revenue in 2014 to slightly increase from 2013's level. Net loss for 2014 is expected to be in the range of EUR 7.5 to 8.5 million. In line with the expected net loss range, cash consumption for the fiscal year 2014 is projected at a slightly increased level compared to 2013 in the range of EUR 7.0 to 8.0 million.

Epigenomics AG, Q2 2014 Earnings Call, Aug 12, 2014

Epigenomics AG, Q2 2014 Earnings Call, Aug 12, 2014

Epigenomics AG Announces Publication of Results of Two U.S. Clinical Studies with its Blood-Based EPI Procolon(R) CRC Screening Test

Epigenomics AG announced that results from its U.S. clinical validation study for its blood-based colorectal cancer (CRC) detection test Epi proColon(R) as well as from its head-to-head comparative study with fecal immunochemical occult blood testing (FIT) have been published in renowned scientific journals. Both clinical studies are part of the required data package to seek regulatory approval of Epi proColon(R) in the U.S. The peer-reviewed article, 'Validation of a Real-Time PCR-Based Qualitative Assay for the Detection of Methylated Sept9 DNA in Human Plasma', discussing the data of Epigenomics' U.S. pivotal clinical validation study has been published online on Clinical Chemistry and will subsequently appear in the journal's print issue. Based on prospectively collected plasma samples from a cohort of approximately 8,000 average risk individuals, the study was designed to measure the clinical performance of Epi proColon(R) for the detection of CRC in comparison to colonoscopy. The data published in Clinical Chemistry elaborates on top-line data Epigenomics announced in December 2011. In this clinical study Epi proColon(R) detected 68% of colorectal cancer cases (sensitivity) while correctly identifying 80% of the patients free of disease (specificity). The study results establish the clinical performance of Epi proColon(R) and suggest that under the assumption that choice drives improvement in CRC screening participation, this novel test has the potential to reach the otherwise non-compliant patients. In addition, the peer-reviewed publication, 'Plasma Septin9 versus Fecal Immunochemical Testing for Colorectal Cancer Screening: A Prospective Multicenter Study', discussing the top-line data of the head-to-head comparative study of Epi proColon(R) versus FIT has recently been published online on PLOS ONE. The study was designed to demonstrate the non-inferiority of Epi proColon(R) in detection of CRC in comparison to one of the most commonly used FIT products in the U.S. market and was performed at 61 clinical sites across the U.S. The published data elaborate on the top-line data Epigenomics announced in December 2012. Sensitivity of Epi proColon(R) in detecting patients with CRC was 73% versus 68% for FIT. Specificity of Epi proColon(R) was 82% versus 97% for FIT. The study results confirm the performance of the assay and indicated that Epi proColon(R) met the critically important endpoint of non-inferiority with respect to sensitivity to the FIT test in detecting CRC.


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