Epigenomics AG / Key word(s): Miscellaneous 02.06.2014 / 21:30 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(R) in other regions Company remains committed to offer highly efficient and convenient alternative for CRC screening […]
Category: Press Releases
02. June 2014
Epigenomics AG: FDA Issues Response Letter for Epigenomics’ Colorectal Cancer Screening Blood Test Epi proColon(R) Requesting Further Data Pre-Approval
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13. May 2014
Epigenomics AG: Epigenomics AG Announces Q1 2014 Financial Results and Reports on Operational Highlights
Epigenomics AG / Key word(s): Quarter Results 13.05.2014 / 08:30 Berlin (Germany) and Germantown, MD (U.S.A.), May 13, 2014 – 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. Q1 2014 revenue increased by 14% compared to […]
29. April 2014
Epigenomics AG: Epigenomics Updates on Regulatory Status for Epi proColon(R) in the U.S.A.
Epigenomics AG / Key word(s): Miscellaneous 29.04.2014 / 09:00 Berlin (Germany), Germantown, MD (U.S.A.), April 29, 2014 – 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(R), the Company’s blood-based […]
24. April 2014
Epigenomics AG: Epigenomics’ Partner BioChain Successfully Completes Clinical Validation Study for CFDA Approval of Epi proColon(R) in China
Epigenomics AG / Key word(s): Study/Miscellaneous 24.04.2014 / 12:10 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(R) with the CFDA, expecting commercialization of the test to start in 2015 […]
28. March 2014
Epigenomics AG: Epigenomics AG Publishes 2013 Annual Report and Provides Outlook for the Year 2014
Epigenomics AG / Key word(s): Final Results 28.03.2014 / 08:30 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(R), Epigenomics provides an outlook for 2014, expecting revenue and net loss slightly increased compared to 2013 FDA Advisory […]
27. March 2014
Epigenomics AG: FDA Advisory Committee Provides Recommendations for Epigenomics’ Colorectal Cancer Screening Blood Test
Epigenomics AG / Key word(s): Regulatory Admission 27.03.2014 / 07:00 FDA Advisory Committee votes favorably that the benefits of Epi proColon(R) 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 […]