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Year: 2014

Epigenomics’ Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon® in China

74.8% sensitivity and 97.4% specificity demonstrated in cohort of 1,074 patients; results in line with those achieved in the European CE marking study reported in 2011 BioChain filed for regulatory approval of Epi proColon® with the CFDA, expecting commercialization of the test to start in 2015

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Epigenomics’ Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon® in China

Berlin (Germany), Germantown, MD, and Newark, CA (U.S.A.), Beijing (China) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), and BioChain Institute Inc. (BioChain), today announced that BioChain has completed its major clinical validation study to validate Epigenomics’ blood-based Septin9 screening assay Epi proColon® for the early detection of colorectal cancer (CRC) with the goal […]

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Epigenomics AG Publishes 2013 Annual Report and Provides Outlook for the Year 2014

PDF 92 KB Company confirms preliminary financial results for the fiscal year ending December 31, 2013 announced on February 26, 2014 Prior to securing U.S. market approval for Epi proColon®, Epigenomics provides an outlook for 2014, expecting revenue and net loss slightly increased compared to 2013 FDA Advisory Committee provides recommendations for Epigenomics’ colorectal cancer […]

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Epigenomics AG: FDA Advisory Committee Provides Recommendations for Epigenomics’ Colorectal Cancer Screening Blood Test

PDF 122 KB FDA Advisory Committee votes favorably that the benefits of Epi proColon® outweigh the risks Berlin (Germany) and Germantown, MD (U.S.A.), March 27, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced the outcome of a meeting of the Molecular and Clinical Genetics Panel […]

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Epigenomics AG: FDA Advisory Committee Provides Recommendations for Epigenomics’ Colorectal Cancer Screening Blood Test

PDF 45 KB   FDA Advisory Committee votes favorably that the benefits of Epi proColon® 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 […]

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Epigenomics and VSA receive approval to market Epi proColon in Argentina

PDF 59 KB Berlin (Germany), Germantown, MD (U.S.A.) and Buenos Aires (Argentina) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, and VSA ALTA COMPLEJIDAD S.A. (VSA), a leading Argentinean pharmaceutical and blood diagnostics company announced today that VSA has received approval to market the Epigenomics Epi proColon® kit […]

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