NEW YORK (GenomeWeb News) – German molecular diagnostics company Curetis said today it anticipates filing a 510(k) submission with the US Food and Drug Administration for its Unyvero System in 2014.
In preparation of a submission, the company has begun a clinical trial for the system and its lower respiratory tract (LRT) application. Curetis expects the trial to last between 12 and 15 months.
The CE-marked Unyvero System uses PCR technology to isolate, amplify, and detect DNA for bacteria and antibiotic resistance from a single sample in one run. Results can be obtained in about four hours, Curetis said, adding that the first CE-marked Unyvero cartridge, Unyvero P50, is for pneumonia testing and simultaneously analyzes 39 DNA targets.
A second Unyvero application for implant and tissue infections is in product development, and in the pipeline are cartridges for other ailments such as bloodstream infections and tuberculosis.
Curetis' clinical trial for the system will include samples from more than 2,000 hospitalized patients suspected of having lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. The Unyvero Lysator will be used to process the samples, which will then be transferred to the LRT cartridge and tested on the Unyvero Analyzer.
"Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to microbiology culture (today's diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative," Curetis said.
The LRT application analyzes 39 DNA targets simultaneously from a single patient sample and results can be obtained within four hours, the company said.