OpGen on Tuesday announced top line data from a completed clinical trial to evaluate its Unyvero UTI Panel, a quantitative test for a broad range of bacterial and fungal pathogens and antimicrobial resistance markers.
Based on all of the data generated and analyzed, OpGen will start preparing a de novo request package over the next few months for submission to the U.S. Food and Drug Administration (FDA) with the aim of obtaining marketing clearance for the panel.
According to OpGen, the trial was designed to evaluate the performance of the Unyvero UTI Panel for detecting urinary tract infections (UTIs) using clean-catch or catheter-related urine samples.
Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was met by demonstrating an overall weighted average sensitivity of 96.4% and overall weighted average specificity of 97.4% when compared against each trial site’s standard of care microbiology results, OpGen said.
The trial included 1,858 prospective and archived samples and more than 3,300 Unyvero cartridges, including controls and reproducibility tests performed at the different trial sites.
In addition to local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory, OpGen is obtaining next-generation sequencing data at its Rockville, MD, lab facility to enable genotypic correlation of antibiotic resistance markers detected during the study.
Based on the results of the unblinded data set, testing of additional contrived samples with well-characterized pathogen strains will complement and provide additional data points for low prevalence strains and antibiotic resistance markers, the firm said.