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%.