OpGen, Inc. announced that it has submitted a De Novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for its Unyvero UTI Urinary Tract Infection (UTI) panel, following successful completion of its 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 against various reference tests, using clean-catch or catheter related urine samples.

Across all prospectively enrolled samples, the primary study endpoint was successfully met by demonstrating an overall weighted average sensitivity of 96.8% and overall weighted average specificity of 97.4% when compared against each trial site's standard of care microbiology results. Since completion of enrollment, OpGen has performed testing of contrived samples with well characterized strains to provide additional data for low-prevalence strains and antibiotic resistance markers at its facility in Germany and generated next-generation sequencing (NGS) data at its Rockville, Maryland, lab facility to establish genotypic correlation of antibiotic resistance markers detected during the study. OpGen will present data from the study at the ASM Microbe 2023 conference in Houston, TX, on June 17, 2023, and together with the principal investigators also intends to submit for a peer reviewed publication.