Benzinga -
- OpGen Inc (NASDAQ: OPGN) announced topline data from its Unyvero urinary tract infections (UTI) clinical trial.
- OpGen's Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens and antimicrobial resistance markers directly from urine specimens.
- The test aims at the 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.
- The study met the primary endpoint and exhibited an overall weighted average sensitivity of 96.4% and an overall weighted average specificity of 97.4% when compared against each trial site's standard of care microbiology results.
- Related: OpGen Stock Gains On FDA Approval, Interim Q3 Sales.
- The trial included 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.
- Based on all the data generated and analyzed, OpGen will start preparing a De Novo request package for submission to the FDA in due course.
- OpGen intends to present data at a future conference and submit it for a peer-reviewed publication.
- Price Action: OPGN shares are up 146.30% at $0.30 on the last check Tuesday.