Advanced Technology Company (ATC) negotiated exclusive rights to distribute Curetis’ CE-marked Unyvero™ bacterial and drug resistance diagnostics system in the six Gulf Cooperation Council (GCC) countries and the Lebanon. A clinical evaluation program for the system has been approved to start in Kuwait; meanwhile placement of the instruments will start from the third quarter of this year.
“At present, no other region in the world has such a rapidly growing demand for improved diagnostics of infectious diseases,” comments Oliver Schacht, Curetis CEO. At the same time, there is a need to realign and modernize local healthcare systems in the Middle East. There is a rising prevalence of antimicrobial resistance, and only recently the World Health Organization and the GCC governments have started a joint effort to address the problem.”
Unyvero is a qualitative nucleic acid multiplex test system for the simultaneous detection and identification of nucleic acids associated with a range of bacteria and antibiotic resistance. The system comprises a Lysator instrument, which automatically prepares the sample, the disposable cartridges that contain all the reagents required to complete the analysis of the prepared sample, on the Unyvero analyzer. The cartridges contain all the reagents required for DNA purification, PCR set-up, multiplex end-point PCR and amplicon detection by hybridization to oligo probes spotted on membrane arrays. The Unyvero Lysator and the Unyvero Analyzer are controlled by the Unyvero C8 Cockpit running Unyvero-specific software. A dedicated server software is also available to enable communication between the Unyvero Cockpit and external systems such as hospital servers or laboratory information systems.
The first CE-marked Unyvero Cartridge, Unyvero P50 is designed for pneumonia testing, and simultaneously assays for 39 DNA targets. Cartridges for additional applications including surgical site infections, blood stream infections, and tuberculosis are in development. Both the Unyvero suite of instruments and the P50 cartridge were granted a CE mark in May.