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Curetis seeks FDA approval for Unyvero platform and LRT application cartridge

MDBR Staff Writer Published 06 January 2017

Molecular diagnostics firm Curetis is seeking approval from the US Food and Drug Administration (FDA) for its Unyvero platform and Unyvero LRT lower respiratory tract cartridge.

The company submitted a 510(k) application with the FDA for Unyvero to be used for the diagnosis of lower respiratory tract infections.

The LRT panel panel features 36 analytes for all key pathogens and antibiotic resistances.

Curetis submission was based on data from the FDA trial, which compared performance of the Unyvero LRT lower tract respiratory tract cartridge in detecting respiratory pathogens to microbiology culture.

The study also compared the results of Unyvero to a composite of microbiology and independent PCR tests and sequencing.

According to the firm, the trial included about 2,202 prospective and retrospective samples and reached its primary endpoints.

In addition, the firm already commenced preparations for another FDA trial with its Unyvero ITI application cartridge to diagnose joint infections such as periprosthetic joint infections.

With the plans to launch in this year, the trial is expected to complete by the end of this year.

Curetis COO Johannes Bacher said: "With the timely submission of our FDA filing for Unyvero and the LRT Application Cartridge, we have met yet another key milestone as laid out during our IPO.

"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."