Firm claims automated multiplex Unyvero system can detect infections and drug resistance within three hours.
Infectious disease diagnostics firm Curetis increased its Series A financing round to a total of €24.5 million (roughly $36 million) through an investment by CD-Venture. All Curetis’ existing investors had already participated in the fundraising. The firm says the funds will be used in part to enable the commercial launch and roll-out next year of its multiplex Unyvero platform, together with an initial CE-marked IVD test cartridge for pneumonia and antibiotic resistance. Curetis also plans to push on with starting a U.S. clinical trial with the IVD product later this year, with a view to filing for FDA approval in 2012.
German firm Curetis’ Unyvero platform is designed to detect broad panels of bacteria and antibiotic resistance from a single sample and generate results within about three hours. The fully automated multiplexed DNA-based assays are carried out in a disposable cartridge that provides all the reagents necessary to complete the analysis from sample-in to result. Curetis says multiplexing is achieved by combining the sample preparation and PCR technology with a proprietary detection array.
The Unyvero platform includes an automated sample preparation technology carried out in the automated Unyvero Lysator instrument. The firm says the process is capable of preparing DNA from a range of micro-organisms in complex native samples within a few minutes including sputum, bronchoalveolar lavage, and protected brush specimen.
Lysed samples are then transferred to the Unyvero cartridge for PCR and analysis on the automated Unyvero A50 Analyzer. The disposable cartridge integrates all sample analysis steps including 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, which runs the necessary software to guide the user through the workflow and also communicates results to external systems such as hospital servers or Laboratory Information Systems.
The first cartridge to be developed for the system is the Unyvero pneumonia cartridge, which is designed to analyze over 50 DNA targets simultaneously. Over 17 clinically relevant pneumonia-causing bacteria are included in the panel, together with resistance genes. Additional cartridges in development will detect pathogens including Gram-negative and Gram-positive bacteria, mycobacteria, fungi, and viruses, together with associated antibiotic resistance markers.