NEW YORK – OpGen announced on Tuesday that it has submitted a de novo classification request to the US Food and Drug Administration for its Unyvero Urinary Tract Infection (UTI) panel. The submission follows successful completion of its clinical trial of the assay.
The highly multiplexed UTI panel provides quantitative detection of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens.
The submission was based on results from a large multicenter study including more than 1,800 patient samples, the Rockville, Maryland-based firm said in a statement.
OpGen said the trial compared the Unyvero UTI panel to various reference tests using different urine sample collection methods. The overall weighted average sensitivity and specificity for the assay was 96.8 percent and 97.4 percent, respectively.
The firm has also tested contrived samples consisting of well-characterized strains at its facility in Germany to provide additional data for low-prevalence strains and antibiotic resistance markers and has generated next-generation sequencing data at its Rockville, Maryland, lab facility to establish genotypic correlation of antibiotic resistance markers detected during the study.
"Following the in-depth analysis of all of our clinical trial data, we have compiled a comprehensive submission package for our de novo classification request, building on a large dataset of Unyvero data and multiple reference methods," said Johannes Bacher, CEO of OpGen, in a statement.
"This marks a major milestone, and we’re looking forward to working closely with the FDA during the interactive review for the Unyvero UTI panel, which we hope [will] become the first high multiplex molecular diagnostic IVD for urine samples granted by the FDA," he added.
The firm expects to present the trial data at the upcoming American Society of Microbiology (ASM) Microbe meeting in June and to publish the data in a peer-reviewed journal. A recent study of its highly multiplexed Unyvero Hospitalized Pneumonia (HPN) panel showed that it reduced the duration of inappropriate antibiotic therapy by an average of 38.6 hours.