Tag: Unyvero™
Company News: Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commercialization
– Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national and international commercialization activities. The performance evaluation of Curetis´ Unyvero™ System and the Unyvero™ P50 Pneumonia cartridge was successfully completed just recently.
The evaluation has demonstrated excellent performance characteristics of the Unyvero™ pneumonia application in terms of sensitivity and specificity. Overall sensitivity in 186 tested fresh and frozen clinical sputum, aspirate and lavage samples was above 75% sensitivity with a better than 95% specificity. The Unyvero™ P50 pneumonia application cartridge identified 74 additional pathogens missed by standard microbiology culture, which was used as gold-standard comparator in terms of performance. If confirmed with independent methods this might demonstrate that the Unyvero™ pneumonia test offers significant improvements in terms of sensitivity over current clinical standards. This analysis is ongoing.
Cartridge and instrument system have also passed other important criteria, such as repeatability, reproducibility, interference testing, and cross-reactivity. The complete performance evaluation study included 318 Unyvero™ P50 cartridge runs between January and April 2012.
Based on positive feedback from many potential distribution partners during the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) earlier this year, Curetis has also begun establishing its international distributor network and expects to target an even broader international market than originally anticipated beginning in 2012/13 already.
Company News: Curetis AG to Present Its Unyvero™ System for Pneumonia Diagnostics
– Demonstration supported by symposium on bacterial pneumonia and emerging antibiotic resistance at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the presentation of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge during the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in London.
The showcasing will be accompanied by the Curetis-sponsored Integrated Symposium “Bacterial Pneumonia and Emerging Antibiotic Resistance”, which will focus on pneumonia-causing pathogens, their respective antibiotic resistances, and the relevance of multiplexed molecular diagnostic testing. The event will be chaired by clinical microbiologist and molecular diagnostics specialist Prof. Christine Ginocchio (North Shore-LIJ Health System School of Medicine, New York), and Prof. Keith Klugman (Emory University, Atlanta), the world’s premier expert on antibiotic resistance among pneumococcal bacteria.
The Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to report. The Unyvero™ P50 Cartridge is the first cartridge developed by Curetis AG and focuses on pathogen as well as antibiotic resistance testing for pneumonia. Each cartridge handles one patient sample and simultaneously analyzes 39 DNA targets. Results are available within less than 4 hours.
Company News: Curetis AG Initiates Prospective Clinical Trial for Rapid Pneumonia Diagnostics
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.
The prospective, international, multicenter trial will enroll up to 1,000 hospitalized patients suspected with a lower respiratory tract infection. Patient samples such as sputa, aspirates or bronchial lavages will be pre-processed by the Unyvero™ Lysator and transferred to the Unyvero™ P50 Pneumonia cartridge, which is analyzed by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to today’s diagnostics standard of care, microbiology culture. Trial sites include the University Hospital Tuebingen, Germany, the Heart and Diabetes Center Bad Oeynhausen, Germany, the Hospital Clinic of Barcelona in Spain, the Erasme Hospital in Brussels/Belgium, and the University Hospital Jena, Germany. Principal investigator is Prof. Dr. Ingo B. Autenrieth of the University Hospital Tuebingen. Interim topline data are expected for spring 2012.
Company News: Curetis Appoints Dr. Klaus Brinkmann as Director of Sales
– Preparation of CE-marking and product launch in Europe in 2012 –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that Dr. Klaus Brinkmann has joined its management team as Director of Sales.
Dr. Klaus Brinkmann is a seasoned executive with extensive commercial expertise in setting-up sales organizations and infrastructures and leading sales teams in very competitive markets. He has an outstanding track record in the commercialization of complex in vitro diagnostics (IVD). His experience covers instrument platforms as well as test kits in the areas of immunology, traditional microbiology and molecular-based infectious disease testing. He joins Curetis from BioRad Laboratories GmbH, where he has been Account Manager Lab Automation. Previously, he held various sales management positions with Becton Dickinson GmbH and Beckman Coulter GmbH. Klaus Brinkmann studied chemistry and holds a doctorate from Justus Liebig University Giessen, Germany.