• Successfull Completion of Clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application
• Clinical sensitivity across 40-marker panel averages 94% at 99.4% specificity

Curetis AG have successfully completed 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.

“The successful completion of the CE performance evaluation study demonstrates significant performance improvements over our previous P50 Pneumonia cartridge,” said Dr. Gerd Lüdke, Director Bio-Assay Development of Curetis AG. “It also underscores our commitment to evolving our multiplex panels according to the changing landscape of antibiotic resistance and pathogens. We believe the Unyvero P55 cartridge offers an unparalleled panel of pathogen detection and antibiotic resistance marker analysis from any native respiratory clinical sample type within four to five hours.”

“The addition of critical carbapenem resistance markers as well as several important pathogens underlines the unique multiplexing offered by the Unyvero Solution,” said Prof. Dr. Brigitte König, Institute of Medical Microbiology and Infection Epidemiology, University Hospital Leipzig. “We are looking forward to seeing the clinical data and to introducing this enhanced and expanded application cartridge into our clinical routine.”

Further details on the Unyvero platform are available at the new Unyvero product website, www.unyvero.com. The new site details the Unyvero range of products and hosts key Unyvero scientific and clinical publications and posters for download.

Investigational device. Limited by Federal (or United States) law to investigational use only.