Curetis NV, Amsterdam, the Netherlands, has submitted an application for FDA premarket notification (510(k)) clearance of the Unyvero platform and Unyvero lower respiratory tract (LRT) cartridge.

The Unyvero system automates and integrates DNA purification, eight parallel multiplex endpoint polymerase chain reaction (PCR) processes, and the detection of amplicons using hybridization on arrays in a disposable cartridge.

The FDA submission seeks clearance 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-resistant organisms in this indication area.

The submission is based on data from the company’s clinical trial comparing the performance of the Unyvero cartridge to microbiology culture, the current diagnostic gold standard, for detecting respiratory pathogens. The trial also compared Unyvero results to a composite of microbiology and independent PCR tests plus sequencing.

The Unyvero study included a total of 2,202 prospective and retrospective samples, and demonstrated 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 system delivered microorganism and resistance marker results in approximately 5 hours, whereas microbiology culture methods required an average of 3 to 4 days for the completion of microorganism identification and antibiotic susceptibility testing.

The trial was complemented by a study using a set of contrived samples, including negative patient samples spiked with rare pathogens and analytes at known concentrations. Processing of these samples was conducted at four trial sites, with results showing an overall weighted average of 87.6% agreement for all tested pathogens. All in all, more than 10,000 LRT cartridges were run during the trial, including comprehensive analytical and preclinical testing.

Together with the participating study centers, Curetis is preparing the clinical trial results for publication.

“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 initial public offering,” says Johannes Bacher, chief operating officer of Curetis. “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.”

“With the first FDA trial completed, we are well on track toward launching our Unyvero platform in the USA in 2017,” says Oliver Schacht, PhD, CEO of Curetis. “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. In addition, we will continue to drive additional application cartridges and menu expansions by conducting further US FDA trials.”

Curetis has already started preparations for another 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.

For more information, visit Curetis.