Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections.
The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect 15 genetic markers of antibiotic resistances.
The company plans to launch the diagnostic at the European Congress of Clinical Microbiology and Infectious Diseases this week.
In a 443-sample study, the test achieved 95.6% sensitivity and 99.3% specificity. The positive predictive value of the diagnostic was 95.8% and the negative predictive value was 99.2%, Curetis noted.
“This new product further enhances our portfolio of Unyvero cartridges for hospital-acquired infections,” Dr. Achim Plum, Curetis’ chief business officer, said in prepared remarks. “With the launch of Unyvero UTI, clinicians now have access to Unyvero cartridges that cover all primary infections which may lead to sepsis, still the number one cause of morbidity and mortality worldwide and the most significant cause of death in non-coronary intensive care units.”
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