Date: 2012-10-09
Type of information:
phase:
Announcement: completion of patient enrollment
Company: Curetis (Germany)
Product: Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge
Action
mechanism: 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 analyzes 39 DNA targets simultaneously. Results are available within less than 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical significance. Further cartridges for the diagnosis of surgical site infections, blood stream infections and tuberculosis are in preparation.
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 result.
The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure.
Disease: pneumonia
respiratory tract infection
Therapeutic area: Infectious diseases - Respiratory diseases
Country: European Union (including Germany, Spain, Belgium)
Trial
details: 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.. The first Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. Cartridges for further applications, e.g. for surgical site infections, blood stream infections and tuberculosis, are in preparation.
Latest
news: * On October 9, 2012, Curetis has announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012 in just 7 months. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.The trial will compare the performance of the Unyvero™ P50 Pneumonia Cartridge with conventional microbiology culture, the current standard of care. Primary endpoint will be clinical sensitivity and speci? city for the identi? cation of 17 pathogens covered by the Unyvero™ P50 panel. Secondary endpoints include time to result and correlation of resistance marker detection with phenotypic antibiograms. Curetis will conduct systematic discrepant results resolution by PCR and sequencing to con?rm the clinical truth in samples where Unyvero results differ from microbiology culture. The study complements the previously completed CE performance evaluation study, in which the Unyvero P50 Cartridge identi?ed a signi?cant number of additional pathogens not detected by microbiology culture. These ? ndings were con?rmed by PCR analysis.
* On February 16, 2012, Curetis has announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.
