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Curetis Submits Unyvero System, Respiratory Infection Panel for FDA Approval

NEW YORK (GenomeWeb) – German molecular diagnostics firm Curetis announced today that it has submitted its Unyvero system and Unyvero lower respiratory tract (LRT) panel for approval to the US Food and Drug Administration.

Unyvero is an automated, benchtop, cartridge-based molecular testing platform that combines proprietary universal sample prep with endpoint PCR and array-based detection. The LRT cartridge is designed for critical lower respiratory tract infections, which can be mistaken for pneumonia, and detects 21 different pathogens and 19 resistance markers. Both the system and cartridge are CE marked in Europe.

The FDA submission follows Curetis' completion of a clinical trial that compared the LRT panel to both microbiology and individual PCR testing plus sequencing in 2,202 prospective and retrospective samples, and demonstrated that it has 91.4 percent sensitivity and 99.5 percent specificity.

"The trial resulted in a very comprehensive and strong data package that will hopefully allow for getting a clearance decision in 2017 and has confirmed the substantial reduction in time-to-result that can be achieved with Unyvero," Curetis Chief Operating Officer Johannes Bacher said in a statement.

Curetis CEO Oliver Schacht added that the company anticipates launching the Unyvero system in the US this year and has already hired a marketing director and scientific affairs director for its San Diego office.

"Once we have clarity on the FDA process and timelines, we will start building a field-based sales and service organization and a back office support team of around 20 additional staff during 2017," Schacht said. "In addition, we will continue to drive additional application cartridges and menu expansions by conducting further US FDA trials."

Curetis said it has already begun preparations for a US clinical study of a Unyvero panel for joint infection diagnosis. That trial is expected to start this year and wrap up in 2018.

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