Curetis Initiates Clinical CE Performance Evaluation of Unyvero P55 Pneumonia Application

- Clinical study to test more than 400 patient samples
- Follows successful completion of analytical CE Performance Evaluation in more than 400 cartridge runs
- Expected results and product launch in spring 2015

Curetis AG, a developer of next-level molecular diagnostic solutions, today announced the start of the clinical CE performance evaluation of its next-generation Unyvero P55 Pneumonia Application. The new P55 Cartridge will replace the current P50 Pneumonia Application, which was launched in 2012. P55 will offer an even broader panel of pathogens and antibiotic resistance markers, reflecting global changes in the importance of microorganisms and certain critical resistance mechanisms responsible for pneumonia and other lower respiratory tract infections. Final study data and the P55 product will be presented at the upcoming 25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) April, 25 – 28 2015 in Copenhagen, Denmark.

The clinical study will evaluate more than 400 already collected native samples from patients suffering from pneumonia. Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity as compared to microbiology culture, today’s diagnostics standard of care. Analytical sensitivity has already been established for all panel analytes in more than 400 P55 cartridge runs. 

The P55 Cartridge comes with a panel of up to 21 pathogens and up to 19 antibiotic resistance markers. Additions are expected to include e.g. Mycoplasma pneumoniae, Citrobacter freundii, Enterobacter aerogenes, and Klebsiella variicola as well as clinically relevant resistance genes coding for carbapenem (imp, ndm, vim and several oxa-markers) and oxacillin (mecC) resistance. These enhancements reflect input from clinical and epidemiological findings, key opinion leaders and customers over the past two years and will support Curetis’ global product launch activities. 

The new cartridge will replace the P50 Application on the European market. Pricing will remain unchanged, with an international roll-out expected to start in the second quarter of 2015. Under the label LRT55, the P55 Cartridge will also be used as a Lower Respiratory Tract (LRT) Application in the U.S. FDA clearance trial, which is expected to be completed in 2016.

“The landscape of antibiotic resistances and clinically relevant pathogens is quickly changing. The Unyvero P55 Application underlines our commitment to constantly evolve our multiplex panels to meet the latest medical findings,” said Dr. Gerd Lüdke, Director Bio-Assay Development of Curetis. „With P55, we are offering an unparalleled panel of pathogen detection and antibiotic resistance marker analysis suitable to obtain clinically relevant results from any native respiratory patient sample type within 4 to 5 hours.”

“The addition of critical carbapenem resistance markers as well as several microorganisms of increased clinical relevance confirms the unique multiplexing capacity offered by the Unyvero Solution,” said Dr. med. Anne Thews, Medical Director of Curetis. “We are looking forward to the clinical data of the P55 study and we are truly convinced that this enhanced cartridge will add significant value to our customers in daily clinical routine improving the standard of care.”