Curetis Wins CE Mark for POC Diagnostic Platform, Pneumonia Test Cartridge

Molecular diagnostics firm Curetis announced the award of a CE mark for its Unyvero™ point of care diagnostic platform and the first disposable cartridge-based test for the system, P50 Pneumonia. The automated assay is designed to simultaneously test for 39 DNA targets from a range of pneumonia-causing bacteria and determine antibiotic resistance.

The Unyvero system allows the fully automated DNA-based testing of any clinically relevant samples using the disposable cartridge format. The platform integrates pre-analytical and analytical steps into one cartridge that contains all the reagents required to complete analysis from sample to result, including sample conditioning/cell lysing, DNA purification and amplification, and detection. Results are generated within about 3 hours.

Curetis says it is developing additional test cartridges for further applications including surgical site infections, blood stream infections, and tuberculosis.