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Year: 2014

Epigenomics AG Provides Update on Regulatory Status and Information on Additional Clinical Study for Epi proColon® in the U.S.

PDF 74 KB   Berlin (Germany), Germantown, MD (U.S.A.), July 1, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, reports on the status of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) and provides information regarding the design and objectives of an […]

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Epigenomics AG Announces Publication of Results of Two U.S. Clinical Studies with its Blood-based Epi proColon® CRC Screening Test

PDF 127 KB   Berlin (Germany), Germantown, MD (U.S.A.) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced that results from its U.S. clinical validation study for its blood-based colorectal cancer (CRC) detection test Epi proColon® as well as from its head-to-head comparative study with fecal immunochemical […]

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FDA Issues Response Letter for Epigenomics’ Colorectal Cancer Screening Blood Test Epi proColon® Requesting Further Data Pre-Approval

PDF 273 KB   Berlin (Germany) and Germantown, MD (U.S.A.) – Epigenomics AG (ISIN: DE000A1K0516, OTCQX: EPGNY) today announced that it has received a response letter from the U.S. Food and Drug Administration (FDA) in relation to its premarket approval (PMA) application for the Company’s blood-based colorectal cancer (CRC) screening test Epi proColon®. In its […]

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FDA Issues Response Letter for Epigenomics’ Colorectal Cancer Screening Blood Test Epi proColon® Requesting Further Data Pre-Approval

PDF 291 KB Meeting to discuss next steps with FDA scheduled in June FDA decision has no impact on commercialization of Septin9-based tests by LDT partners or existing commercial arrangements for Epi proColon® in other regions Company remains committed to offer highly efficient and convenient alternative for CRC screening

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Epigenomics AG Announces Q1 2014 Financial Results and Reports on Operational Highlights

PDF 185 KB Berlin (Germany) and Germantown, MD (U.S.A.) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced its financial results for the first quarter ending March 31, 2014.

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Epigenomics Updates on Regulatory Status for Epi proColon® in the U.S.A.

PDF 70 KB   Berlin (Germany), Germantown, MD (U.S.A.) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today provides an update on the status of its discussions with the Food and Drug Administration (FDA) regarding Epi proColon®, the Company’s blood-based colorectal cancer (CRC) screening test, following a recent […]

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