In Vitro Diagnostics – IVD News

– 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 to be initiated in 2019 – Investigating optimal path for CFDA approval in China Berlin (Germany) and San Diego, CA (U.S.A.), July 2, 2018 – Epigenomics AG (FSE: ECX,…

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 Netherlands; San Diego, CA, USA; and Holzgerlingen, Germany; April 19, 2018, 01:00 EDT — Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level…

– 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, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, April 03, 2018, 15:45 am EDT – Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH,…

– 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 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today announced that Acumen Research Laboratories Pte. Ltd. (Acumen), its partner for…

– 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 Holzgerlingen, Germany, March 06, 2018, 06:00 am EST – Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic…

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 antibiotics to use. Schacht says they expect the FDA to approve the platform and first product in the U.S. which is a test for life-threatening ammonia. Schacht says he…

– 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 molecular test for Sepsis Host Response panel licensed from Acumen in preparation Amsterdam, the Netherlands, and Holzgerlingen, Germany, February 06, 2018;  — Curetis N.V. (the “Company” and, together with Curetis…

– 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 Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, January 08, 2018, 01:00 am EST – Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis”),…

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 searches for a combination of DNA methylation biomarkers in order to detect cancer, the company said. The assay was partly developed with funding from the European Commission within the…

Curetis Publishes Business and Financial Update for the First Nine Months of 2017 – Preparing for expected U.S. FDA clearance decision on Unyvero System and Unyvero LRT Application – Second U.S. FDA trial initiated for Unyvero IJI Application Amsterdam, the Netherlands, and Holzgerlingen, Germany, November 16, 2017; published at 02:00 a.m. EDT – Curetis N.V. (the “Company” and,…