Molecular diagnostics expert Curetis NV has filed for US FDA clearance of Unyvero LRT to speed up diagnosis of patients with lower respiratory tract (LRT) infections.
With its 510(k) application to the US Food and Drug Administration (FDA), Curetis targets the US diagostics market for lower respiratory infections such pneumomia for use with BAL (bronchoalveolar lavage) specimens. The Unyvero LRT BAL panel covers 50 diagnostic targets with 30 assays for the most clinically relevant pathogens. The PCR-based panel also identifies antibiotic resistance genes.
The submission is based on clinical data from a cohort of patient samples collected at nine sites during the Company’s US FDA LRT trial as well as a cohort of additional retrospective samples known to be positive for one or more pathogens, comparing the performance of the Unyvero LRT BAL Lower Respiratory Tract Cartridge in detecting respiratory pathogens to the current diagnostic standard of care, i.e. microbiology culture. The trial also compared Unyvero results to a composite comparator of microbiology and independent PCR tests plus DNA sequencing.
In total, the study included more than 1,400 patient samples from the combined prospective and retrospective cohorts and demonstrated an overall weighted average sensitivity of 90.1% and 94.7% and an overall average weighted specificity of 98.4% and 97.9% across all pathogens in the prospective and retrospective cohorts, respectively. Application of the Unyvero test delivered microorganism and resistance marker results in approximately five hours, whereas the standard-of-care based on microbiology culture methods required several days on average to complete microorganism identification and antibiotic susceptibility testing of a patient sample.
The study was complemented by an additional set of 240 contrived samples, which successfully confirmed performance of LRT BAL with negative patient samples that were spiked with rare pathogens and resistance markers at known concentrations. All in all, more than 5,500 LRT BAL cartridges were run as part of the comprehensive analytical and clinical performance evaluation.
“With this second FDA submission filed, we are well on track towards expanding the utility of our Unyvero LRT panel in the USA to also include BAL specimens in addition to tracheal aspirates,” said Oliver Schacht, CEO of Curetis.
