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Curetis MDx System, Pneumonia Test Cleared in Russia, Serbia

NEW YORK (GenomeWeb News) — Curetis said today that its Unyvero system and its Unyvero P50 pneumonia assay have been registered and cleared by the Russian and Serbian Ministries of Health.

The first Unyvero system has already been installed at the Central Clinical Hospital of the Presidential Administration of the Russian Federation in Moscow and another will be tested at a major hospital in St. Petersburg, Curetis said.

Curetis' distribution partner, BioLine, is currently presenting the Unyvero system at major clinical and scientific events in Russia. Likewise, Curetis' distribution partner Ako Med is demonstrating the system at major hospitals in Serbia, Bosnia-Herzegovina, Croatia, and Slovenia.

Unyvero is an automated, benchtop, cartridge-based molecular testing platform that combines proprietary universal sample prep with endpoint PCR and array-based detection to detect a broad panel of bacteria, fungi, and antibiotic resistances from a single sample in one run.

Curetis, based in Holzgerlingen, Germany, currently markets Unyvero in Europe, Russia, the Middle East, and various other non-European countries. In the US, Curetis is running a prospective multi-center clinical trial aimed at achieving US Food and Drug Administration clearance.

The first CE-marked Unyvero cartridge, Unyvero P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. The second application, the Unyvero i60 ITI cartridge for implant and tissue infections, is in late-stage product development. It covers 114 targets from many native clinical sample types and eight distinct clinical indications. The company is preparing cartridges for additional indications.

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