In Vitro Diagnostics – IVD News

– 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,…

Curetis initiates U.S. FDA Study for Unyvero Invasive Joint Infections Cartridge –      Initial patient samples collected for second U.S. Unyvero Product Study –      Prospective clinical trial expected to start in 2018 Amsterdam, the Netherlands, and Holzgerlingen, Germany, October 23, 2017; published at 09:00 a.m. EDT — Curetis N.V. (the “Company” together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic…

MGI and Curetis to Collaborate on NGS-based Infectious Disease Diagnostics –        Broad collaboration to develop a targeted Next-Generation Sequencing assay for microbial infections –        Workflow for native samples integrating MGI and Curetis instrumentation –        Curetis’ subsidiary Ares Genetics to provide assay design and data interpretation app  Amsterdam, the Netherlands, and Holzgerlingen, Germany, September 12, 2017; published at 07 am ET —…

BERLIN, and GERMANTOWN, Md., Aug. 30, 2017 /PRNewswire/ — Epigenomics AG (Frankfurt Prime Standard: ECX) (OTCQX: EPGNY), today announced the initiation of a Post Approval Study (PAS), Performance of Epi proColon in Repeated Testing in the Intended Use Population (PERT) – NCT03218423. The PERT trial is being conducted in concert with the US Food and…

  – Trial sponsored by University Clinic RWTH Aachen investigates personalized treatment approaches with Biotest’s Pentaglobin® in peritonitis patients – Curetis to provide testing services for different samples from up to 200 patients with its recently launched Unyvero IAI Application for intra-abdominal infections Amsterdam, the Netherlands, and Holzgerlingen, Germany, August 15, 2017; published at 08:00…