Curetis N.V. announced it has submitted a 510(k) application to the U.S. Food and Drug Administration for its Unyvero Platform and the Unyvero LRT Lower Respiratory Tract Cartridge. The submission is for the use of Unyvero for the diagnosis of lower respiratory tract infections. The LRT panel includes up to 36 analytes for all key pathogens and antibiotic resistances in this indication area. The submission is based on clinical data of the Company's U.S. FDA trial comparing the performance of the Unyvero LRT Lower Respiratory Tract Cartridge in detecting respiratory pathogens to microbiology culture, the current diagnostic standard of care. The trial also compared Unyvero results to a composite of microbiology and independent PCR tests plus sequencing. The study included a total of 2,202 prospective and retrospective samples and met its primary endpoints by demonstrating an overall weighted average sensitivity of 91.4% across all pathogens of the final panel definition as well as an overall average weighted specificity of 99.5%, which increased to 99.8% after discrepant result resolution. The Unyvero application delivered microorganism and resistance marker results in approximately 5 hours, whereas microbiology culture methods required three to four days on average until microorganism identification and antibiotic susceptibility testing of a sample has been completed. The study was complemented by a set of contrived samples, i.e. negative patient samples spiked with rare pathogens and analytes at known concentrations. This part was successfully completed at four trial sites with data showing an overall weighted average positive percent agreement (PPA) for all tested pathogens of 87.6%. All in all, more than 10,000 LRT cartridges were run in the trial, including comprehensive analytical and pre-clinical testing. Together with the participating study centers, Curetis is preparing a publication of the clinical trial data. An abstract will be submitted for peer review and for presentation at one of the major upcoming U.S. medical diagnostics conferences. Curetis has already started preparations for another FDA trial with its Unyvero ITI Application Cartridge for the diagnosis of joint infections, including periprosthetic joint infections. The company expects to launch this trial in 2017 with the aim of completion in 2018.