– Company Successfully Completes Clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application
– Clinical sensitivity across 40-marker panel averages 94% at 99.4% specificity
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the successful completion of the clinical and analytical CE performance evaluation of its next-generation Unyvero P55 Pneumonia Application. The upgraded cartridge will launch at the 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID, April 25 – 28, 2015 in Copenhagen, Denmark) and is supported by more than 800 cartridge runs and over 400 patient samples.
Unyvero P55, which is replacing the current P50 cartridge, identified a total of 127 additional pathogens compared to microbiology culture. Discrepant results have been resolved by independent PCR and sequencing and validated 93 cases as true positives, e.g. cases where traditional microbiology culture missed the pathogen.
The Unyvero P55 Pneumonia Application demonstrates superiority over culture and key enhancements compared to the P50 cartridge, evidenced by pathogen and resistance expansions and improved sensitivity proven in the CE clinical performance study. Specific upgrades include:
- Expansion to detect 21 pathogens, including new targets Mycoplasma pneumoniae, Citrobacter freundii, Enterobacter aerogenes and Klebsiella variicola
- Addition of critical antibiotic resistance markers (now a total of 19), including genes coding for carbapenem (imp, ndm, vim, oxa-23, oxa-24, oxa-48, and oxa-58 markers) and oxacillin (mecC) resistance
- Improvements to sensitivity for several analytes, i.e.
- Greater than 90% for most pathogens on the P55 panel, including Pseudomonas aeruginosa
- Greater than 92% for Staphylococcus aureus
- Near 100% for Pneumocystis, E. coli and Moraxella catharralis.
Comprehensive data supporting the next-generation Pneumonia Application will be presented at ECCMID.
The European and international roll out (excluding North America) commences in April 2015. Pricing for the P55 Pneumonia Application remains unchanged from the P50 cartridge. In the U.S., the P55 is being used under the label LRT55 as a Lower Respiratory Tract (LRT) Application in a U.S. FDA clearance trial, which is expected to be completed in 2016.