Heraeus Medical and Curetis inked an agreement to jointly develop a Unyvero diagnostic cartridge for detecting pathogens and antibiotic resistances in implant and tissue infections (ITI). They suggest one of the major applications of the diagnostic will be in diagnosing infections after orthopedic surgery including knee and hip replacements, though potential applications will span diagnosing infections caused by biofilms on implants, as well as abdominal surgery, diabetic foot, or burn wound infections. Under terms of the deal the two firms will co-fund product development.
Curetis’ CE-marked Unyvero has been developed as a fully automated system for the DNA-based diagnosis of a broad panel of bacteria and antibiotic resistance based on a disposable cartridge format. The first CE-marked cartridge, Unyvero P50, is a pneumonia test that analyzes 39 DNA targets. Cartridges for applications such as bloodstream infections and tuberculosis are also in development.
The 40–50-strong panel of bacteria and antibiotic resistance analytes for the ITI cartridge has been selected following consultation with experts throughout Europe. Launch in the EU is expected by the end of 2013. “There is a need for a highly accurate implant/orthopedic infection test for mixed pathogens,” comments André Kobelt, CEO at Heraeus Medical, which specializes in the development of bone cement and biomaterials for elective orthopedic and trauma surgery. “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.”
Curetis’ Unyvero™ suite of instruments and P50 Pneumonia cartridge achieved a CE mark in May. The deal with Heraeus follows on from a research and development collaboration signed last month with Cempra, through which the latter will incorporate sputum sample testing with the Unyvero™ P50 diagnostic into an upcoming global Phase III trial evaluating its oral solithromycin in patients with community-acquired bacterial pneumonia (CABP).