Tag: Oliver Schacht
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 to Present Clinical Unyvero™ Data at Major Scientific Conferences
– Lower Respiratory Tract application: initial clinical evaluation data from U.S. center will be presented at ICAAC 2013 (USA)
– New application Implant and Tissue Infections: first data will be presented at DGHM/DGI meeting (Germany)
Curetis AG today announced the upcoming presentation of new clinical data on two Unyvero™ applications at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2013) in Denver, CO (Sept. 10-13) and 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 (Sept. 22-25).
Curetis will introduce clinical data from a U.S. pre-FDA trial phase of its Unyvero™ LRT (Lower Respiratory Tract) infection application at the ICAAC conference. The poster ‘Evaluation of a Molecular Multiplex Test For Detection of Respiratory Microorganism and Antibiotic Resistance Genes in Clinical Specimens’[1] will present data generated at Northwestern Memorial Hospital (Chicago, IL) during the initial familiarization and training phase for the FDA trial. The FDA trial is now being conducted at four sites; all clinical data are blinded until completion of this ongoing trial which is expected for 2014. The LRT application is already marketed and branded outside the U.S. as the Unyvero™ P50 pneumonia application. During ICAAC, Curetis will also showcase its Unyvero™ Solution at booth no. 822 in the exhibition hall.
Moreover, Curetis will present data of its novel Unyvero™ i60 ITI application for the diagnosis of implant and tissue infections detecting pathogens and resistance markers at the annual DGHM/DGI meeting. The poster presentation ‘A new Multiplex PCR-Panel for the Detection of Pathogens Related to Implant and Tissue Infection’[2] will introduce the panel chosen for the diagnosis of eight indication areas and present initial validation and verification data with clinical samples. Curetis will also host the industry symposium ‘Implant and Tissue Infections – A Diagnostic Challenge’ (Sept. 24, 12:15-1:15pm, Auditorium 2) featuring talks and case studies by Prof. Petra Gastmeier (Berlin, Germany), Dr. Anne Thews (Holzgerlingen, Germany), Prof. Andrej Trampuz (Berlin, Germany), and Dr. Olivier Borens (Lausanne, Switzerland). A second poster based on data independently generated at the University Hospital in Basel, Switzerland will present a ‘Comparison of the Unyvero™ Pneumonia P50 Assay with standard culture and antimicrobial susceptibility testing’.[3]
[1] Presentation D-1655a, Session: #214 – Diagnosis and Epidemiology of Respiratory Infections, Sept. 13, 8:30-10:30am, Exhibit Hall A.
[2] Presentation DVP02, Postersession I (StAG Diagnostic Microbiology and Microbiology Procedures Quality Standards), Sept. 23, 3:00pm, Auditorium 1
[3] Presentation KMP14, Postersession II (StAG Clinical Microbiology and Infectious Diseases), Sept. 24, 3:00pm, Room HS323.
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.