Molecular diagnostics firm Curetis this week announced the availability of new data on the clinical performance of its Unyvero P50 pneumonia cartridge in multi-pathogen infections.
Researchers from private laboratory medicine firm MVZ Dr. Eberhard & Partner in Dortmund, Germany, analyzed pneumonia patient samples using both Curetis' Unyvero P50 pneumonia cartridge and classical microbiology culture, and determined that Unyvero P50 had greater than 80 percent sensitivity with greater than 95 percent specificity for pathogen identification.
Of note, Curetis said, 54 percent of all cases had polymicrobial infections, many of them involving between three and six different pathogens. In the trial, Unyvero P50 found additional polymicrobial infections and detected 17 pathogens, all of which were not identified by microbiology culture. In contrast, in six cases classical culture identified a total of eight pathogens not detected by Unyvero P50.
"The results suggest that combining rapid molecular methods such as the Unyvero solution with traditional microbiology culture can be a huge advantage in assessing the optimum treatment regime," Arthur Pranada, lead author of the study and a specialist for microbiology, virology, and infectious disease epidemiology at MVZ Eberhard, said in a statement. "This is of great importance in many polymicrobial infections and with challenging native respiratory samples."
Anne Thews, medical director at Curetis, added in a statement that the company is "excited to see our laboratory partners and customers conduct clinical studies on important medical questions such as polymicrobial infections. The data show that both methods are synergistic, with Unyvero delivering results after only four to five hours compared to several days for classical microbiology."
The new data were presented last month at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC, and will also be presented next week at Microbiology and Infection 2014, a joint event of the Association for General and Applied Microbiology and the Society of Hygiene and Microbiology in Dresden, Germany.
The Unyvero P50 cartridge focuses on pneumonia testing and simultaneously analyses 39 DNA targets. It runs on the CE-marked Unyvero Analyzer, an automated benchtop nucleic acid testing platform that combines a proprietary universal sample prep method with endpoint PCR and array-based detection. The system is designed to detect a broad panel of bacteria, fungi, and antibiotic resistances from a single sample in one run.
Curetis markets the platform in Europe, Russia, the Middle East, and various other non-European countries. A second CE-marked application, the Unyvero i60 ITI cartridge for implant and tissue infections, is also commercially available in Europe, while cartridges for additional indications are in various stages of development and preparation.
In the US, Curetis is running a prospective multi-center clinical trial aimed at achieving US Food and Drug Administration clearance.