News

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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Curetis to Launch CE-IVD Unyvero Blood Culture Application Cartridge at ECCMID 2016

Curetis to Launch CE-IVD Unyvero Blood Culture Application Cartridge at ECCMID 2016 – Successful completion of CE Performance Evaluation Study – Covers 103 diagnostic targets with 87 pathogens and 16 resistance markers Amsterdam, the Netherlands and Holzgerlingen, Germany, March 23, 2016 — Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of…

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Curetis Blood Culture CE-IVD

Curetis Validating Blood Culture Cartridge for CE-IVD Launch in Q2 Mar 03, 2016 NEW YORK (GenomeWeb) – In preparation for a CE-IVD launch in the second quarter, Curetis has initiated the final performance evaluation of its BCU Blood Culture Application cartridge to diagnose bloodstream infections. The Holzgerlingen, Germany-based company is also gathering momentum from its…

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Curetis Validation of Blood Culture Cartridge

Curetis Starts Final Validation Study for New Unyvero Blood Culture Application Cartridge – Data and CE-IVD launch expected in Q2, 2016 – Company also prepares launch of 2nd generation ITI Application Cartridge and novel product for intra-abdominal infections Amsterdam, the Netherlands and Holzgerlingen, Germany, February 23, 2016 — Curetis N.V. (the “Company” and, together with…

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