Tag: Curetis AG
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.
Company News: Curetis Presents New Clinical Validation Data on its Unyvero™ P50 Pneumonia / LRT Application
– Clinical studies from U.S. and Switzerland confirm previous performance data
– Findings presented at DGHM/DGI 2013 and ICAAC 2013
Curetis AG today announced the presentation of additional clinical validation data on its Unyvero™ P50 / LRT application at two international conferences. The cartridge is designed to detect 16 respiratory bacteria and one fungus responsible for about 80% of severe non-viral pneumonia cases. In addition, it is able to simultaneously identify 22 antibiotic resistance markers.
At this year’s 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO, researchers from the Northwestern Memorial Hospital (Chicago, IL) and Curetis presented data generated during the initial familiarization and training phase for the FDA trial of the Unyvero™ LRT application, an investigational device. It is based on the panel of the P50 cartridge, which is already marketed outside the U.S. In the small cohort using native clinical samples, the Unyvero™ LRT application achieved an overall sensitivity of 89% and an overall specificity of 98% for pathogen identification. Moreover, it detected 6 additional pathogens not discovered by routine microbiological culture. The resistance markers showed an overall sensitivity of 87% at an overall specificity of 97%. The authors conclude that “this data indicates that the system can significantly contribute to patient management by providing rapid pathogen identification and antimicrobial resistance profiling.”
At the 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, clinicians from the University Hospital Basel, Switzerland, presented data comparing the Unyvero™ P50 cartridge with standard microbiological culture, including anti-microbial susceptibility testing. While in 104 cases microbiology culture detected 96 pathogens evaluable by the Unyvero™ P50 cartridge, P50 detected 73 pathogens (76%). However, Unyvero™ P50 detected 68 microorganisms that were not listed in the culture report. Of these, 46% were S. pneumoniae and 10% were H. influenzae – pathogens difficult to culture or part of the oral flora for which clinical significance is not yet determined. The discrepancies are still under investigation. Phenotypic antimicrobial susceptibility or resistance was predicted correctly in 82% of cases by Unyvero™ P50. While standard culture and anti-microbial susceptibility testing took 2 to 4 days, the Unyvero™ results were obtained in less than 4.5 hours. The Basel microbiology team concluded that the “Unyvero™ Pneumonia P50 assay is able to provide fast and clinically useful results on the most prevalent pathogens causing pneumonia and their antibiotic resistance genes.”
A previous study testing more than 1,000 samples in Europe showed an overall sensitivity of 81% and an overall specificity of 96%.
Company News: Curetis Initiates Prospective Multicenter Unyvero™ Study in Europe
– Study to demonstrate added value of Unyvero™ P50 pneumonia application in clinical routine –
Curetis AG today announced the start of an additional prospective, multicenter clinical trial of its marketed Unyvero™ P50 Pneumonia Application to demonstrate its clinical and health economic value.
The CE performance evaluation completed last year already demonstrated 81% sensitivity at 99% specificity for detecting pneumonia-causing pathogens. Following the market launch in April 2012, Curetis in 2013 presented data from more than 1,000 patient samples showing overall sensitivity of its pathogen panel of 80.6% at a specificity of 96% (ECCMID European Conference of Clinical Microbiology and Infectious Diseases, Berlin).[1]
The new multicenter study aims to establish real-world data on the health economic impact of fast, patient-near molecular testing and subsequent therapy adjustments (if necessary). It will be conducted in five leading European centers and will involve several hundred critically ill patients with pneumonia requiring mechanical ventilation. The study is designed to first evaluate the current pneumonia treatment and clinical outcome situation by detailed chart reviews comparing patients having received initial adequate, respectively inadequate treatment. Data will be used to fine tune endpoints for the interventional, randomized second part of the study, which aims to investigate the potential clinical and economic benefit of the Unyvero™ system. Parameters analyzed will be, e.g. type of antibiotic regimen and costs, length of stay in the ICU, etc.
Participating clinicians are world-renowned intensive care, pulmonology and microbiology specialists: Prof. Manfred Quintel (University of Goettingen), Prof. Tobias Welte (MHH University Clinic Hanover), Prof.s Philippe Eggimann and Gilbert Greub (CHUV University Hospital of Lausanne), Prof. Mathias Pletz (Jena University) and Prof. Antoni Torres (University Hospital Clinic Barcelona).
Preliminary results of the study are expected by the end of this year.
[1] Abstract Nr. 2360: M. Klein et al., First clinical validation of a rapid molecular test (Unyvero™ P50 Pneumonia Application) detecting microorganisms and antibiotic resistances in patients suspected with severe pneumonia.