Curetis and Heraeus Join to Develop Infection Detection Device

Curetis AG and Heraeus Medical GmbH are jointly developing a cartridge for the detection of pathogens and antibiotic resistances in implant and tissue infections (ITI). The cartridge will be developed under the Curetis hardware platform, Unyvero. One key application area will be in orthopedics, specifically to diagnose infections after knee and hip replacement surgeries.

The Unyvero platform is CE Marked for the detection of various bacteria and antibiotic resistances from a single sample. It processes a disposable cartridge that provides the necessary reagents to complete an analysis from sample to result.

Under 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 (a denotation for the dominant German language countries Germany, Austria and Switzerland) as well as through its international distributor network. The resulting Unyvero cartridge and application will be a Curetis-labeled in vitro diagnostic.

Heraeus hopes to leverage this partnership to provide in vitro and molecular diagnostic solutions to its customers. Both companies hope the new ITI cartridge will be applicable to general surgery, but also in infections caused by biofilms (such as those that develop on knee and hip implants or in catheters), in abdominal surgery infections, diabetic foot ulcers, and burn wounds, among other segments.

Wound and surgical site infections increasingly are caused by bacteria carrying multiple antibiotic resistances. In orthopedic indications, infections often involve biofilms, communities of microorganisms that are difficult to open up and cultivate. It currently may take seven to 15 days to obtain results from biofilm samples, Curetis officials claim. This scenario often leads to prolonged empiric treatment, follow-up surgeries and increased morbidity and healthcare costs.

Curetis and Heraeus report they jointly have conducted market research in orthopedic applications throughout Europe for the development of the new cartridge. They also have teamed up with clinical key opinion leaders in Germany, Switzerland, France, the United Kingdom 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 next year and an expected launch in the European Union 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/orthopedic infection test for mixed pathogens; the diagnostic field is for Heraeus Medical—a leader in infection management in orthopedics—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 orthopedic infection.”

“The collaboration with Heraeus Medical provides us with the opportunity to leverage our Unyvero platform 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 four hours. The collaboration is in line with our goal of maintaining full strategic and commercial freedom in our partnerships.”

Curetis AG is a molecular diagnostics company that focuses on the development and commercialization of products for diagnosing severe infectious diseases. The company is headquartered in Holzgerlingen, Germany.

Hanau, Germany-based Heraeus Medical GmbH specializes in precious metals and their application in medical devices. The company develops, manufactures and markets biomaterials and accessories targeted at improving surgical results in bone and joint surgery as well as infection management.

Image of the Unyvero P50 pneumonia cartridge courtesy of Curetis AG.