OpGen, Inc. announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen's Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens. The test aims at quantitative detection of microorganisms. The trial was designed to compare the performance of the Unyvero UTI Panel for detecting urinary tract infections (UTI), using clean-catch or catheter related urine samples.

Preliminary analysis of all prospectively enrolled samples showed that the primary study endpoint was successfully 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. These findings are also in line with the interim analysis performed during the first part of the trial. The trial included a total of 1,858 prospective and archived samples and has run over 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 currently generating next-generation sequencing (NGS) data at its Rockville, MD, lab facility to also allow 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. Based on all the data generated and analyzed, OpGen will now start preparing a De Novo request package for submission to the U.S. FDA in due course.