Penny Stock OpGen Surges After UTI Panel Test Meets Primary Goal In Clinical Trial

Vandana Singh
1 min read
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In this article:

  • 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.

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