Curetis N.V. (the "Company" together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced it has started collecting patient samples for a multi center FDA study for its Unyvero IJI Cartridge for the detection of invasive joint infections. The cartridge will be a newly developed U.S. version based on the CE IVD marked Unyvero ITI Cartridge already marketed in Europe and other parts of the world. The Unyvero IJI Cartridge is the second Unyvero application to undergo a U.S. FDA study. Clearance decision by the FDA for the Unyvero LRT (Lower Respiratory Tract) Infections Application, Curetis’ first Unyvero U.S. product, is expected by the end of 2017.
Following Institutional Review Board (IRB) approvals, the first patient samples were collected in early October. Among the sites that have already entered the trial for sample collection of microbiology-positive synovial fluid patient samples are sites that previously participated in the Unyvero LRT trial (e.g. Beaumont Hospital, Royal Oak, MI), as well as new sites (e.g. Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, WI), med fusion, (Lewisville, TX) and a leading reference lab in the Southwest. The Company is expecting further expansion of the network to include additional sites in the coming months.