Tag: Clinical CE Performance Evaluation

Company News: Curetis to Launch Next-Generation Pneumonia Application at ECCMID 2015

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.

Company News: 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.