Tag: Curetis
Company News: Curetis Joins European Prosthetic Joint Infection Cohort Study (EPJIC)
– Unyvero i60 ITI cartridges to be run on 500 prospectively collected patient samples from multi-center study across Europe
– All Unyvero testing to be conducted in central reference lab under the auspices of the PRO-IMPLANT Foundation and Prof. Andrej Trampuz
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced it has joined the European Prosthetic Joint Infection Cohort Study (EPJIC). EPJIC is an initiative of the PRO-IMPLANT Foundation to improve the management of Prosthetic Joint Infection (PJI) and to develop consensus guidelines across Europe. PJI is one of the leading causes of joint implant failure. Treatment often requires multiple surgical interventions and prolonged antibiotic therapy and is associated with a failure rate of 10 to 20 percent.
The investigator-initiated study has started in September 2014 and will enroll up to 5,000 PJI patients from up to 100 study centers across Europe. As part of the study, 500 patient samples will be measured by the Unyvero i60 ITI multiplex PCR cartridge system to identify pathogens involved in prosthetic joint infection, a key indication area of the Unyvero i60 ITI cartridge. The data will help build the body of evidence especially in PJI diagnosis using sonication fluid samples. As already demonstrated in the CE performance evaluation study of the i60 cartridge, the Unyvero system is able to detect pathogens frequently missed by microbiology culture. Also, Unyvero i60 results are available within about 5 hours compared to classical microbiological culture methods that can take up to 14 days with PJI samples.
The study’s Unyvero arm is expected to be completed by the end of 2015, with initial data anticipated in the first half of 2015. Data will be published at major conferences and in peer-reviewed scientific journals.
The Unyvero i60 cartridge, which is jointly marketed by Curetis and Heraeus Medical GmbH, 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. Its multiplex panel covers a total of 114 targets – 91 pathogens (gram-negative & gram-positive bacteria and fungi) and 23 resistance markers – relevant for eight clinical indications.
In combination with the unique Unyvero L4 Lysator, it can process biofilm samples, an important prerequisite for the fast and reliable diagnosis of implant infections (catheters, joints etc.).
Company News: Curetis Presents New Unyvero Pneumonia Data at Major Clinical Microbiology Meetings
– Presentation of clinical data from a pneumonia study on multi-pathogen infections at ICAAC 2014 and DGHM 2014
– Rapid Multiplex PCR assays confirmed as valuable addition to conventional testing methods
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced new data on the clinical performance of its Unyvero P50 pneumonia cartridge in multi-pathogen infections.
A study conducted by researchers from private laboratory medicine firm MVZ Dr. Eberhard & Partner (Dortmund, Germany) analyzed pneumonia patient samples with both Curetis’ Unyvero P50 pneumonia cartridge and with classical microbiology culture. The investigator-initiated study determined >80% sensitivity at >95% specificity for pathogen identification with Unyvero P50. Of note, 54% of all cases had polymicrobial infections, many of them involving between 3 and 6 different pathogens. In the trial, Unyvero P50 found additional polymicrobial infections and detected 17 pathogens, all of which were not identified by microbiology culture. In contrast, in 6 cases classical culture identified a total of 8 pathogens not detected by Unyvero P50.
The data have been presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C. (U.S.) and will also be presented at the upcoming conference Microbiology and Infection 2014 in Dresden (Germany), a joint event of the Association for General and Applied Microbiology (VAAM) and the Society of Hygiene and Microbiology (DGHM).
During Microbiology and Infection 2014, Curetis will host a symposium on the “Clinical Relevance of Rapid Infectious Disease Diagnostics”. It will take place on Monday, October 6, from 12:15pm – 1:15 pm CET (Room: Konferenz 1 / International Congress Center Dresden). The symposium will be chaired by Prof. Dr. Helmut Fickenscher (Kiel University). Presentations will be held by Dr. Reno Frei (University of Basel) and Prof. Dr. Maria Déja (Charité – Universitaetsmedizin Berlin).
Company News: Mayo Clinic’s Dr. Robin Patel Named Principal Investigator for Curetis’ Unyvero™ LRT Trial
– Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Robin Patel, M.D., Professor of Medicine and Microbiology at the Mayo Clinic in Rochester, Minn., has been named Lead Principal Investigator of the company’s Unyvero™ LRT Application FDA trial. The lower respiratory tract (LRT) application is designed to detect 17 pathogens and 22 antibiotic resistance gene markers of clinical importance in patients with suspected LRT infections. The Company also announced the addition of six new clinical trial sites in the last few quarters, expanding its clinical trial network to nine high-profile testing sites.
Dr. Patel, who chairs the Division of Clinical Microbiology and Mayo Clinic’s Bacteriology Laboratory and directs the Infectious Diseases Research Laboratory, is a specialist in the clinical detection and identification of bacteria, including the characterization of their antimicrobial resistance and susceptibility, particularly for biofilm-mediated infections. She succeeds Prof. Christine Ginocchio, M.D., formerly of North Shore-LIJ Health System Laboratories, who recently left North Shore-LIJ to assume a corporate position in the microbiology field.
To bolster enrollment and to capture potential geographical differences in pathogen and antibiotic resistance gene distribution, Curetis has also expanded its clinical trial network from three to nine testing sites over the past couple of quarters.
Participating trial centers testing at least 2,000 prospective lower respiratory tract samples include:
- David Geffen School of Medicine at UCLA (Los Angeles, Calif.)
- Johns Hopkins University School of Medicine (Baltimore, Md.)
- Northwestern Memorial Hospital (Chicago, Ill.)
- Mayo Clinic (Rochester, Minn.)
- North Shore-LIJ Health System Laboratories (Lake Success, N.Y.)
- University of Rochester Medical Center (Rochester, N.Y.)
- Weis Research Center/Geisinger Health System (Danville, Penn.)
- University of Washington Medical Center (Seattle, Wash.)
- William Beaumont Hospital (Royal Oak, Mich.)
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).