OpGen announces positive topline clinical trial data for UTI panel
The precision medicine company announced successful completion of its Unyvero urinary tract infection (UTI) clinical trial with promising results and plans for submission to the FDA.
Diagnosing complicated UTIs remain a major challenge for ob-gyns. Microbiological cultures take several days to produce results, pathogenic microbial species may go undetected for various reasons, and complex polymicrobial infections may be even harder for analysis to reveal.
According to the study results, OpGen’s UTI panel can detect a comprehensive range of pathogenic bacteria, fungi, and their associated resistance markers directly from urine samples in less than 5 hours.
“Rapid results enable early diagnosis and effective antibiotic therapy to help prevent serious complications in UTI patients," said Christopher Emery, MD, associate director of clinical microbiology, Indiana University Health Pathology Laboratory, Indianapolis, Indiana.
The trial included more than 1800 prospective and archived samples and ran more than 3300 UTI panel cartridges—including controls and reproducibility tests—at the 4 US clinical trial sites. According to results, the panel ultimately did so with 96.4% sensitivity and 97.4% specificity.
OpGen is currently awaiting local microbiology laboratory results and additional standardized central microbiology data from an independent reference laboratory. The company plans to incorporate the data and analyses from its completed trial into a submission package for the US Food and Drug Administration in the coming months.
The company has also begun its work on next-generation sequencing data at its lab facility in Maryland to continue to explore genotypic correlation of antibiotic resistance markers detected during the study. Testing additional contrived samples with well-characterized pathogen strains—the company stated—will complement and provide additional data points for low prevalence strains and antibiotic resistance markers.
OpGen will present the in-depth data from the trial at a future conference and in a peer-reviewed publication soon.
Reference
OpGen Announces Positive Top Line Data from Clinical Trial for Unyvero Urinary Tract Infection Panel | OpGen, Inc. OpGen, Inc. Published 2022. Accessed December 20, 2022. https://ir.opgen.com/news-releases/news-release-details/opgen-announces-positive-top-line-data-clinical-trial-unyvero
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