Company News: Curetis and Heraeus Medical Collaborate on the Development of New Unyvero™ Diagnostic Cartridge
– Joint development of cartridge for orthopaedics, wound and surgery infections –
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 orthopaedics, e.g. to diagnose infections after knee and hip replacement surgeries.
Under the terms of the agreement, Heraeus and Curetis will co-fund product development in the respective indication areas. Heraeus’ customers will be given access to the Unyvero™ solution, while Curetis will pay a sales commission for any customer referrals by Heraeus to Curetis. No licenses are involved and further financial details were not disclosed.
Curetis will retain full control over its commercialization strategy and execution both directly in the DACH region as well as via its international distributor network. The resulting Unyvero cartridge and application will be a Curetis-labeled IVD.
The collaboration will provide Heraeus with access to leading-edge, innovative and easy-to-use in vitro diagnostics and molecular diagnostic solutions for its customers. The new ITI cartridge will be of interest not only in general surgery, but also in infections caused by biofilms (e.g. on knee and hip implants or catheters), in abdominal surgery infections, diabetic foot, burn wounds etc.
Today, wound and surgical site infections are increasingly caused by bacteria carrying multiple antibiotic resistances. In orthopaedic 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 orthopaedic 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.
Curetis will present its Unyvero™ solution at the 64th Annual Meeting of the German Society for Hygiene and Microbiology (DGHM) in Hamburg (September 30 – October 3, 2012).