Agreement Announced to Develop New Unyvero Diagnostic Cartridge
20 Sep 2012

Curetis AG and Heraeus Medical GmbH have signed a collaboration agreement to jointly develop a novel Unyvero™ cartridge for the detection of pathogens and antibiotic resistances in implant & tissue infections (ITI). One key application area will be in orthopedics, e.g. to diagnose infections after knee and hip replacement surgeries.

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.

The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure. Thereby, clinically relevant information is available within about four hours to support an informed therapy decision as early as possible.

The first CE-marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses of 39 DNA targets. Cartridges for further applications, e.g. for surgical site infections, blood stream infections and tuberculosis, are in preparation.

Today, wound and surgical site infections are increasingly caused by bacteria carrying multiple antibiotic resistances. In orthopedic indications, infections often involve biofilms, communities of microorganisms very hard to open up and cultivate. At present, it may take 7-15 days to obtain results from biofilm samples. This scenario often leads to prolonged empiric treatment, follow-on surgeries and increased morbidity and healthcare costs.

For the development of the new cartridge, the partners have jointly conducted market research in orthopedic applications throughout Europe. They have also teamed up with clinical key opinion leaders 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 new 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 likely to include more than 40 and possibly up to 50 analytes.

“The collaboration with Heraeus Medical provides us with the opportunity to leveraging our Unyvero platform once again in an important indication, which is only poorly addressed by today’s diagnostic tools,” said Oliver Schacht, CEO of Curetis. “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. The collaboration is in line with our goal of maintaining full strategic and commercial freedom in our partnerships.”

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Sonia Nicholas
Clinical Diagnostics Editor