Pathogens and Antibiotic Resistance Detected in Implant/Tissue Infections

A new ITI cartridge, Unyvero, is being developed not only for general surgery, but also for infections caused by biofilms (e.g., on knee and hip implants or catheters), and for abdominal surgery infections, diabetic foot, burn wounds etc.

Curetis AG (Holzgerlingen, Germany) and Heraeus Medical GmbH (Hanau, Germany) signed a collaboration agreement to jointly develop the Unyvero cartridge for the detection of the cause of infections as well as antibiotic resistances of organisms involved in ITI. The resulting Unyvero cartridge and application will be a Curetis-labeled IVD.

The CE-marked Unyvero System is a versatile hardware platform for the detection of a broad panel of bacteria and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result.

For development of the new cartridge, the two companies conducted market research in orthopedic applications throughout Europe. They also met with clinicians in Germany, Switzerland, France, the UK, and Scandinavia to determine the pathogens and antibiotic resistances that need to be included in the diagnostic panel of the cartridge.

The partners expect assay development for the new cartridge to be completed by early 2013, with clinical validation and CE marking throughout 2013 and an expected launch in the EU by the end of 2013. The product is will probably include more than 40 and possibly up to 50 analytes.

Currently it takes from 7-15 days to obtain results from biofilm samples. This often leads to prolonged treatment, repeated surgeries and increased morbidity and healthcare costs. Oliver Schacht, CEO of Curetis, said, “We offer highly multiplexed analyte panels of pathogens and resistance markers for applications that require the ability to work with a diverse set of native, complex clinical samples and an unmatched ease of use from sample-to-result in about 4 hours.”

Related Links:
Curetis AG
Heraeus Medical GmbH