Tag: Heraeus Medical GmbH
Company News: Curetis Launches Unyvero™ i60 Implant and Tissue Infection Cartridge in Europe
– Successful completion of CE performance evaluation study covering more than 400 patient samples
– Sales and Marketing Program Underway in Germany, Austria and Switzerland
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has launched its new Unyvero™ i60 Implant and Tissue Infection (ITI) cartridge in Europe. The new cartridge for the Unyvero™ system was developed to rapidly identify more than 90 pathogens and more than 20 resistance markers common in eight clinical indications. Commercial launch and roll-out has already begun in close collaboration with Heraeus Medical GmbH, the development and commercialization partner for the Unyvero™ i60 cartridge. The Company has made first placements at major clinical centers in Germany, Austria and Switzerland (DACH market).
The i60 cartridge has been CE-IVD marked following the successful completion of a CE performance evaluation study involving more than 750 cartridges. Analytical sensitivity testing was conducted in 350 cartridges, while more than 400 cartridges were run with patient samples. Samples of various clinical indications were obtained for the trial, including periprosthetic joint infections, diabetic foot, catheters, surgical sites, skin and soft tissue and cardiology-related infections. The Unyvero™ system analyzed challenging native clinical sample types such as swabs, synovial fluid, sonication fluid, tissue and catheters. Among others, the i60 cartridge detected several key pathogens with sensitivities in the range between 75% to 100% at an overall panel sensitivity of 67% and panel specificity of 97.8% for the 81 analytes that have been successfully validated so far. The i60 cartridge also identified 147 clinically important pathogens not found by standard microbiology culture. In particular, in every second sonication fluid and every third synovial fluid sample, i60 detected pathogens missed by microbiology culture. Pathogens most often overlooked by culture, yet identified by i60, were Enterococcus sp., Finegoldia magna, Corynebacterium sp., Enterobacter cloacae, and Acinetobacter baumannii. Resolution of these discrepant results is ongoing.
Curetis and its distribution partners will introduce the Unyvero™ i60 ITI cartridge at the 2014 ECCMID conference in Barcelona, Spain (9-13 May 2014 – Booth 39), where the Company will also host the Medical Symposium, ”Implant and Tissue Infections – Challenges and Opportunities“ (May 10, 2014, from 13:30 – 15:30 in Hall J).
Company News: Curetis Prepares Launch of Second Unyvero™ Application
– Final clinical performance evaluation study for Unyvero™ i60 ITI application ongoing
– Study data expected by the end of Q1/2014
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has completed development of its second Unyvero™ application. The new Unyvero™ i60 ITI cartridge rapidly identifies more than 90 pathogens and more than 20 resistance markers common in implant and tissue infections. After successfully manufacturing several lots and completing initial verification testing of the cartridge, the Company has initiated a pivotal study using approximately 500 cartridges to validate analytical, technical and clinical performance for CE marking.
Following the completion of the study scheduled for end of Q1/2014, commercialization of the Unyvero™ i60 ITI is expected to begin in Q2/2014. Curetis will jointly market the cartridge with Heraeus Medical GmbH, the development and commercialization partner for this cartridge. Both companies have already received pre-orders from key opinion leaders and hospitals across central Europe.
The study will use frozen patient specimens – watery/swabs, viscous/purulent, sonication and synovial fluids, and biopsy material – for diagnosis. The study will compare the molecular test with conventional microbial culture techniques. Discrepant or unexpected results will be resolved by additional tests. The study will also test assay repeatability and reproducibility and establish limit of detection.
Company News: Curetis Presents First Data on Novel Unyvero™ i60 ITI Application for Implant and Tissue Infections
– New cartridge detects 114 targets
– Roll-out in collaboration with Heraeus Medical expected in early 2014
Curetis AG today announced first details on its new Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections. The cartridge has been developed in close collaboration with Heraeus Medical GmbH, a company focused on orthopedic biomaterials. The data were presented at this year´s 65th Joint Annual Meeting of the German Society for Hygiene and Microbiology and the German Society for Infectious Diseases (DGHM/DGI 2013) in Rostock, Germany.
The new Unyvero™ System cartridge covers a broad range of infections common after abdominal as well as bone and joint surgery, trauma (e.g. burns) or skin and soft tissue infections, including diabetic foot disease. In combination with the unique Unyvero™ L4 Lysator it is also possible to process biofilm samples, an important prerequisite for the fast and reliable diagnosis of implant infections (catheters, joints etc.).
The multiplex panel of the novel i60 application covers a total of 114 targets – 91 pathogens (gram-negative & gram-positive bacteria and fungi) and 23 resistance markers – relevant for eight clinical indications. At the conference, Curetis presented data from first evaluation studies demonstrating that the panel is able to detect pathogens in orthopedic and surgically relevant fresh and frozen samples, such as synovial and sonication fluids, swabs, and tissue material. All results were confirmed by standard microbiology culture. Of note, the i60 application also detected additional pathogens not covered by standard methods, e.g. anaerobic bacteria known to be involved in biofilm-formation on orthopedic implants.
Following the successful completion of assay development, Curetis is now running validation and verification tests. The company aims to run a clinical CE performance evaluation study this fall with a goal of obtaining CE-IVD marking for the Unyvero™ i60 ITI cartridge by the end of 2013.