In Vitro Diagnostics – IVD News

Curetis Provides Update on Unyvero LRT FDA 510(k) Submission – Curetis reiterates that it expects FDA to provide decision on clearance of Unyvero LRT in the second half of 2017 Amsterdam, the Netherlands, and Holzgerlingen, Germany, May 24, 2017 – Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular…

Curetis Files for U.S. FDA Clearance for Unyvero Platform and LRT Application Cartridge – Final panel demonstrates overall weighted average sensitivity of 91.4% and overall weighted average specificity of 99.5% across all lower respiratory tract panel pathogens – Unyvero results available after approximately five hours only, compared to three to four days on average for…

Curetis Completes Development of Unyvero Cartridge for Intra-Abdominal Infections – Highly multiplexed panel covers up to 112 diagnostic targets – Third new panel developed within one year after IPO Amsterdam, the Netherlands, and Holzgerlingen, Germany, January 04, 2017 – Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic…

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…

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…

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…

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,…

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…

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…

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…