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Curetis Gets CE Mark for UTI Test

NEW YORK (GenomeWeb) – Dutch diagnostics firm Curetis announced today that it has received CE-IVD marking for its Unyvero UTI test cartridge for the diagnosis of severe urinary tract infections.

The PCR-based cartridge runs on the company's Unyvero platform — which was approved in the US earlier this month and received CE marking in 2012 — and covers 103 diagnostic targets. It detects 88 pathogens, including Gram-positive and Gram-negative species, as well as anaerobic bacteria and the pathogenic fungus Candida auris. It also detects 15 genetic markers of antibiotic resistance.

The cartridge is set for commercial launch in Europe later this month.

"This new product further enhances our portfolio of Unyvero cartridges for hospital-acquired infections," Curetis Chief Business Officer Achim Plum said in a statement. "With the launch of Unyvero UTI, clinicians now have access to Unyvero cartridges that cover all primary infections [that] may lead to sepsis."