OpGen, Inc. (NASDAQ: OPGN) is engaged as a precision medicine company that is focused on developing molecular diagnostics and bioinformatics to help fight infectious diseases. Shares of the diagnostic company are skyrocketing 206% through early trading on Tuesday, December 13, 2022. Over the past three months, OpGen has seen average daily volume of 408,550 shares. However, volume of 145.83 million shares or dollar volume of around $57.49 million, has already exchanged hands through early trading.
Shares of OpGen are soaring after the company reported positive top line data from its clinical trial of the Unyvero UTI panel to determine diagnostic ability to detect urinary tract infections. The study enrolled over 1,800 patient samples across four U.S.-based clinical trial sites.
OpGen developed the Unyvero UTI panel to help test for a broad range of bacterial and fungal pathogens from urine specimens. The test specifically focuses on quantitative detection of microorganisms.
The primary endpoint was met for Unyvero UTI with an overall weighted average sensitivity reading of 96.4% and an overall weighted average specificity of 97.4% compared to each test site’s standard of care microbiology tests. The results are in line with OpGen’s initial interim results from the first half of the trial.
Using a total of 1,858 prospective and archived samples, the clinical trial utilized over 3,300 Unyvero cartridges in controlled and reproducible lab tests across different trial sites. Based on the strong data from the clinical trial, OpGen says it plans to begin preparing a De Novo request package for submission to the U.S. FDA.
“Having completed the study as planned, we have successfully generated a large and very comprehensive study data set with multiple reference methods. We’d like to thank our study sites for their contributions in generating these data.”, said Johannes Bacher, Chief Operating Officer of OpGen. “Now that we have unblinded the results, we are excited to proceed with our in-depth analysis and compile the data submission to the FDA over the next few months.”
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