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.
“There is a need for a highly accurate implant/orthopaedic infection test for mixed pathogens; the diagnostic field is for Heraeus Medical – a leader in infection management in orthopaedics - an extension of its core business,” said André Kobelt, CEO of Heraeus Medical GmbH. “Therefore, we are happy to team up with Curetis as the Unyvero platform provides customers with superior molecular diagnostics solutions to combat serious infections faster and more effectively, as well as potentially improving the management of latent orthopaedic infection.”
“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.”