News

Curetis Acquires Carpegen RT-qPCT Platform

Curetis Acquires Real-Time qPCR Platform from Carpegen and Systec – Gyronimo Platform offers rapid, quantitative cartridge-based sample-to-answer molecular diagnostic testing – Gyronimo to be fully integrated into Unyvero Platform and suite of products Amsterdam, the Netherlands, and Holzgerlingen, Germany, December 13, 2016 – Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer…

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Curetis Announces Positive Data from FDA Trial

Curetis Announces Positive Top Line Data from U.S. FDA Trial –      Primary endpoint for Unyvero LRT product for lower respiratory tract infections shows overall weighted average sensitivity of 90.2% and overall weighted average specificity of 99.3% –      U.S. FDA submission being prepared Amsterdam, the Netherlands, and Holzgerlingen, Germany, October 25, 2016 — Curetis N.V. (the…

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Curetis Acquires Rights to SIEMENS Database

Curetis Acquires Patents and Rights to Genetic Antibiotic Resistance and Susceptibility (GEAR) Database and Know-How from Siemens – Agreement gives Curetis worldwide rights to database and IP based on Next Generation Sequencing – GEAR significantly enhances Curetis’ leading position in the area of genetic antimicrobial resistance biomarker testing [Original Press Release] Amsterdam, the Netherlands, and…

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Curetis Next Gen Implant and Tissue Infection Cartridge

Curetis to Launch Next Generation CE-IVD Unyvero Implant and Tissue Infection Application Cartridge – Launch follows successful completion of CE Performance Evaluation Study – ITI now covers 102 diagnostic targets, including 85 pathogens and 17 resistance markers Amsterdam, the Netherlands, and Holzgerlingen, Germany, September 6, 2016 Curetis N.V. (the “Company” and, together with Curetis GmbH,…

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Curetis USA, Inc. CEO and Subsidiary

Curetis Appoints Christopher M. Bernard as Chief Executive Officer of Newly-Formed U.S. Subsidiary – Former Chief Commercial Officer of Epic Sciences brings valuable experience in sales, marketing and commercialization of in-vitro diagnostic platforms Amsterdam, the Netherlands, and Holzgerlingen, Germany, July 5, 2016 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer…

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Curetis Completes Enrollment in Unyvero FDA Trial

Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections – Last patient enrolled in prospective arm of IVD trial – More than 2,250 prospective and retrospective samples enrolled in study – Data to be complemented with up to 500 additional contrived samples with focus on rare pathogens Holzgerlingen, Germany, June…

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Curetis CE-IVD Blood Culture Cartridge

Jun 16, 2016 | NEW YORK (GenomeWeb) – Curetis said today that it has received the CE-IVD mark for its Unyvero BCU Blood Culture Application Cartridge and has launched the test in Europe, the Middle East, and Asia. The company said the launch was supported by interim data from an external, prospective, multicenter evaluation comparing…

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Curetis Update

Curetis Publishes First Quarter 2016 Business and Financial Update – Worldwide commercial expansion and US FDA trial on track – Installed base of Unyvero Analyzers increased to 107 devices Amsterdam, the Netherlands and Holzgerlingen, Germany, May 20, 2016 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic…

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Epigenomics Receives FDA Approval for Epi proColon

-First and only blood-based colorectal cancer screening test approved by the FDA -Innovative, convenient and effective screening option for millions of eligible Americans -Commercialization initiated with partner Polymedco Berlin (Germany) and Germantown, MD (U.S.A.), April 13, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced that the…

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GBC is Awarded NCI CPTAC Contract

Seattle-based Clinical Research Organization is Awarded a National Cancer Institute (NCI) Contract for Oncology Biospecimen Collection SEATTLE, March 30, 2016  Global BioClinical (GBC), http://www.globalbioclinical.com, is pleased to announce that it has been awarded a contract from the National Institutes of Health (NIH) / National Cancer Institute (NCI) to support the Clinical Proteomics Tumor Analysis Consortium (CPTAC)…

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