Further clinical evaluation study of the Unyvero™ P50 pneumonia cartridge with positive results

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Curetis AG, a company developing innovative diagnostic solutions, announced today positive clinical data from an independent evaluation study of the Unyvero™ P50 pneumonia cartridge. The results of the study from the Department of Medical Microbiology at Maastricht University Medical Center (MUMC) in Maastricht, Netherlands, demonstrate the high clinical sensitivity of the Unyvero™ P50 cartridge in identifying pneumonia pathogens even in samples with low microbial counts.

The scientists compared the performance of the Unyvero™ P50 cartridge with that of conventional microbiological culture in diagnosing ventilator-associated pneumonia (VAP) based on bronchoalveolar lavage fluid samples (BALF). Ventilator-associated pneumonia is a common complication in intensive care patients. The causative agents are mostly infections with Pseudomonas aeruginosa, Staphylococcus aureus, or Enterobacteriaceae.

Compared to the standard (quantitative culture), the Unyvero™ P50 pneumonia cartridge correctly identified eight different important pathogens in all samples (n=44) (100% sensitivity). The overall sensitivity of the Unyvero™ P50 panel was 88.6% at clinically relevant pathogen concentrations. Furthermore, the Unyvero™ P50 cartridge was able to identify eight different clinically relevant pathogens in twelve patient samples that were not detected by conventional microbiological culture. These data confirm previous results, where Unyvero™ repeatedly identified pathogens that were not detected by conventional microbiological techniques.

"Our Unyvero technology has demonstrated outstanding sensitivity even at low pathogen concentrations. Most notably, P50 detected pathogens in 12 samples that could not be identified by conventional microbiology," said Dr. Gerd Luedke, Director of Bio-Assay Development at Curetis. "In just four hours, our technology was able to detect almost 90% of all pathogens and 60% below this threshold."

The data were presented at the scientific spring conference of the Royal Dutch Society for Microbiology (Koninklijke Nederlandse Vereniging voor Microbiologie, KNVM) and the Dutch Society for Medical Environmental Medicine (Nederlandse Vereniging voor Medische Milieukunde, NVMM) in 2014 in Arnhem, Netherlands.

About the Unyvero™ System

The CE-marked Unyvero™ system is a versatile device platform for the identification of various bacteria, fungi, and antibiotic resistances based on a single sample and in one run. The system operates with a single-use cartridge that contains all reagents needed for the entire analysis—from sample preparation to result interpretation. The system is currently marketed in Europe, Russia, the Middle East, and other non-European countries. In the USA, Curetis is conducting a prospective, multi-center study to obtain approval from the American regulatory authority FDA. Study details can be found at www.ClinicalTrials.gov NCT01922024.

The platform enables DNA-based testing of all clinically relevant samples in a fully automated process, requiring no supervision and only a few quick manual preparations. The analysis can thus be performed with minimal labor and without the need for molecular biology specialists or specialized infrastructure.

This allows clinical information to be available within approximately four hours, enabling early and informed treatment decisions.

The first CE-marked cartridge, Unyvero™ P50, is suitable for detecting pathogens and antibiotic resistances in pneumonia and analyzes 39 DNA sequences in parallel. The development of the second cartridge, the Unyvero™ i60 ITI cartridge for the diagnosis of implant and tissue infections, is nearing completion. Additional cartridges are in various stages of development or preparation.

The cartridges are assembled in a cleanroom by Curetis in Bodelshausen. Each cartridge consists of nearly 80 individual plastic injection-molded parts. These 80 plastic parts are assembled into the finished Unyvero cartridges through laser welding, ultrasonic welding, staking, sealing, filling with 200 reagents, and other processes. Currently, up to 500 cartridges are produced in an 8-hour shift per day. The manufacturing site was opened in October 2011 and has been continuously expanded since then. At full capacity in a three-shift operation, up to 1 million cartridges per year could be produced.

About Curetis

Curetis AG, founded in 2007, is a molecular diagnostics company focused on developing and commercializing reliable, rapid, and cost-effective products for diagnosing serious infectious diseases. Curetis' diagnostic solutions enable rapid identification of pathogens and antibiotic resistances within hours, whereas other available techniques require days or weeks.

The company has raised more than €49.1 million (approximately $65 million USD) to date. Its headquarters are in Holzgerlingen near Stuttgart. Curetis has established global cooperation agreements with Heraeus Medical, Sanofi Pasteur, and Cempra Inc., as well as distribution agreements for its Unyvero™ system in more than 20 countries.