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GEN News Highlights : May 14, 2012

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

Automated Unyvero system uses disposable cartridges to test for multiple target sequences and antibiotic resistance.

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.