Why OpGen (OPGN) Shares Are Trading Higher Today – OpGen (NASDAQ:OPGN)

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OpGen Inc 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.