German molecular diagnostic firm Curetis said this week that it has completed development of the second test panel for its Unyvero instrument platform.
The new Unyvero i60 ITI cartridge is designed to rapidly identify more than 90 pathogens and more than 20 resistance markers common in implant and tissue infections. After successfully manufacturing several lots and completing initial verification testing of the cartridge, the company said it has initiated a pivotal study using approximately 500 cartridges to validate analytical, technical, and clinical performance for CE marking.
Curetis said it expects to complete this study at end of the current quarter and begin commercialization of Unyvero i60 ITI in the second quarter of this year. Under a previously disclosed partnership, Curetis will jointly market the product with Heraeus Medical, the development and commercialization partner for this cartridge. Both companies have already received pre-orders from key opinion leaders and hospitals across central Europe.
The study will use frozen patient specimens — watery/swabs, viscous/purulent, sonication and synovial fluids, and biopsy material — and will compare Unyvero i60 ITI with conventional microbial culture techniques. Discrepant or unexpected results will be resolved by additional tests. The study will also test assay repeatability and reproducibility and establish limit of detection, Curetis said.
"Our ITI cartridge combines up to 114 analytes which can be diagnosed in a broad spectrum of highly diverse, native clinical samples obtained from patients with prosthetic joint infections, diabetic foot ulcers, catheter infections, surgical site infections, and many other complex implant and tissue infections," Gerd Lüdke, director of bioassay development at Curetis, said in a statement.
Curetis is also currently in the midst of a clinical trial of more than 2,000 patients for its lower respiratory tract test panel with the goal of obtaining US Food and Drug Administration 510(k) clearance for that cartridge and the Unyvero platform by the end of this year. The instrument system and a modified version of the respiratory tract test cartridge is already CE marked and available for sale in Europe.