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            July 2, 2018
            Published by admin on July 2, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Epigenomics AG: Liquid Biopsy Test for Liver Cancer Detection to Obtain CE Mark

            – Epigenomics plans to CE Mark mSEPT9 blood test for liver cancer by year-end 2018, enabling commercialization in Europe – Prospective U.S. trial for FDA submission […]
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            April 19, 2018
            Published by admin on April 19, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Curetis Launches CE-IVD Marked Unyvero Urinary Tract Infection (UTI) Cartridge

            UTI panel covers 103 diagnostic targets 443-patient multi-center study demonstrates overall weighted average sensitivity of 95.6% at an overall weighted average specificity of 99.3%.  Amsterdam, the […]
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            April 4, 2018
            Published by admin on April 4, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Curetis Receives U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge

            – First ever multiplex MDx test to be granted clearance by the FDA for this indication – Commercial launch in the U.S. expected this quarter Amsterdam, […]
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            April 4, 2018
            Published by admin on April 4, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Curetis Unyvero BCU Blood Culture Application Receives Approval from Singapore Health Sciences Authority

            – Second market authorization for Unyvero Cartridges this year in Singapore Amsterdam, the Netherlands, and Holzgerlingen, Germany, April 04, 2018; published at 11:30 am CEST — […]
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            March 6, 2018
            Published by admin on March 6, 2018
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            • In Vitro Diagnostics - IVD News

            Curetis Subsidiary Ares Genetics Wins Incubator Stay in Silicon Valley

            – Award winner in “GoSiliconValley” competition by Austrian Economic Chambers – Support for business development in U.S. market Amsterdam, the Netherlands, San Diego, CA, USA, and […]
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            February 19, 2018
            Published by admin on February 19, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Curetis Expects Near Term Decision by FDA Approving First Product in US

            16 Feb 2018 – CEO Oliver Schacht from Curetis (EN Amsterdam:CURE) tells Proactive Investors their Unyvero Platform finds killer bugs in hospitals and tells doctors which […]
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            February 6, 2018
            Published by admin on February 6, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Curetis Unyvero Hospitalized Pneumonia Application Receives Singapore Health Sciences Authority Approval

            – Market authorization paves way for broader Unyvero commercial roll-out in ASEAN region through partner Acumen Research Laboratories – Near-term clinical validation study of first cartridge-based […]
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            January 8, 2018
            Published by admin on January 8, 2018
            Categories
            • In Vitro Diagnostics - IVD News

            Curetis Expects Near-Term FDA Decision on De Novo Request for Unyvero LRT

            – Review of the Unyvero System and Lower Respiratory Tract (LRT) Cartridge is nearing completion – U.S. commercial team and operational infrastructure in place Amsterdam, the […]
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            December 20, 2017
            Published by admin on December 20, 2017
            Categories
            • In Vitro Diagnostics - IVD News

            Epigenomics Lung Cancer Test Receives CE-IVD Mark

            Dec 19, 2017 NEW YORK (GenomeWeb) – Epigenomics announced today that it has received CE-IVD marking for its blood-based lung cancer test Epi proLung. Epi proLung […]
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