Company News: Curetis Starts Final Validation Study for New Unyvero Blood Culture Application Cartridge
– Data and CE-IVD launch expected in Q2, 2016
– Company also prepares launch of 2nd generation ITI Application Cartridge and novel product for intra-abdominal infections
Curetis N.V. (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the start of a CE performance evaluation study for its third Unyvero Application Cartridge. The BCU Blood Culture Application Cartridge is designed to diagnose infections that are spreading through the bloodstream and is targeting clinically most relevant microorganisms and related antibiotic resistance markers. Curetis expects data from the study and the subsequent launch of the CE-IVD-marked BCU Application Cartridge in Q2, 2016.
The BCU Application Cartridge features a unique and differentiated test panel covering more than 100 diagnostic targets, including tests to identify Gram-positive and Gram-negative bacteria, fungi and mycobacteria, as well as tests for up to 16 antibiotic resistance markers. The Application Cartridge is using positively flagged blood culture samples from bottles inoculated with blood or punctate. Comprehensive results are delivered within 4 to 5 hours and require just a few minutes of hands-on time.
For the study, the BCU Application Cartridge is being validated in conjunction with the most common commercial blood culture systems, using about 250 blood culture samples. Previous studies testing around 200 BCU cartridges as part of the analytical and pre-clinical performance evaluation were already completed successfully. The data, which are to be published and presented at upcoming conferences, are expected to support the CE-IVD-marking of the BCU Application Cartridge. Three clinical sites in the DACH region already have agreed to further evaluate the Unyvero BCU Application Cartridge in routine clinical settings once it becomes available as a CE-IVD-marked product.
Curetis has also progressed with the development of a second-generation ITI Application Cartridge for implant and tissue infections and has started the development program towards a novel Application Cartridge targeting intra-abdominal infections.
Further pipeline updates and an outlook of additional future product opportunities will be provided in H2, 2016, including an update on the preparation of Curetis’ next US FDA trial for a second Unyvero Application Cartridge for the US market once the ongoing LRT55 FDA trial has been completed.