Curetis Completes Sample Enrollment in Unyvero U.S. FDA Trial in Lower Respiratory Tract Infections - Seite 2

After completion of all molecular comparator testing, data will be unblinded and Unyvero results will be compared against an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. Completion of the analysis is expected in the second half of 2016. Subsequently, a statistical analysis based on more than 350,000 data points combined from microbiology, Unyvero runs, additional molecular testing and bidirectional sequencing will be prepared. FDA submission is anticipated before the end of the year, with a goal of securing FDA clearance for Unyvero and commercialization of the technology in the first half of 2017.

In order to provide additional data points for certain rare pathogens, e.g. Legionella, Mycoplasma, Pneumocystis, up to 500 contrived samples from well characterized pathogen strains from several international strain providers will be spiked into negative matrix and tested with Unyvero at several clinical trial sites. It is expected that this phase will add approximately 1,500 cartridge runs, as double testing will be performed on two systems in parallel for software validation, including daily controls and a number of sample repeats.

LRT55 is a second-generation cartridge based on the design of the CE-IVD marked P55 cartridge marketed outside the U.S. It features 40 markers, a novel control concept and provides the most comprehensive molecular marker panel for lower respiratory tract infections available today.

Further details about the Unyvero platform are available at the Unyvero product website - www.unyvero.com.

Disclaimer

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on the Curetis Unyvero technology is currently available for sale in the United States of America or Canada. The analytical and clinical performance characteristics of any Curetis Unyvero product which may be sold at some future point in time in the U.S. have not yet been established.

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About Curetis

Founded in 2007, Curetis is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis enable rapid multi-parameter pathogen and antibiotic resistance marker detection in only a few hours, a process that today can take up to days or even weeks with other techniques.