Company News: New Favorable Clinical Evaluation Data for Unyvero™ P50 Pneumonia Application

Dutch study demonstrates excellent sensitivity of Unyvero™ cartridges –

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced positive clinical data from an independent study conducted by researchers from the Department of Medical Microbiology of Maastricht University Medical Center (MUMC), Maastricht, the Netherlands. The data demonstrate the high clinical sensitivity of the Unyvero™ P50 Pneumonia application in detecting pathogens, including samples with low pathogen concentrations.

The researchers compared the performance of the Unyvero™ P50 cartridge with conventional microbiology culture in broncho-alveolar lavage fluid (BALF) samples for the diagnosis of ventilator-associated pneumonia (VAP), a common complication in intensive care patients. The most frequent causes are Pseudomonas aeruginosa, Staphylococcus aureus and Enterobacteriaceae.

Using the quantitative culture standard, Unyvero™ P50 Pneumonia correctly detected 8 different important pathogens in all VAP samples (n=44) at 100% sensitivity. The overall sensitivity of the Unyvero™ P50 panel was 88.6% at clinically relevant pathogen concentration. Unyvero™ P50 was also able to detect 8 different clinically relevant pathogens in 12 patient samples where conventional microbiology culture failed. This data confirms previous results where Unyvero™ had consistently detected pathogens missed by conventional culture.

The data were presented at the Scientific Spring Meeting of the Koninklijke Nederlandse Vereniging voor Microbiologie (Royal Dutch Society for Microbiology) KNVM and Nederlandse Vereniging voor Medische Milieukunde (Dutch Association for Environmental Medicine) NVMM 2014 in Arnhem, The Netherlands.