OpGen - Test menu expansion opportunity with positive data
OpGen has announced encouraging final data from its Unyvero Urinary Tract Infection (UTI) panel, a diagnostic test designed to detect pathogens and antimicrobial resistance markers related to UTI, from native urine specimens without the need for culturing. The study, which recruited over 1,800 patient samples across four trial sites in the United States, met its primary endpoint with an overall weighted average sensitivity of 96.4% and specificity of 97.4% in preliminary analysis. The favourable data should support an FDA De Novo application, which we anticipate in Q123 followed by likely launch in 2024, provided FDA clearance is received. The company also plans to submit the data for a peer review publication, which we believe would further strengthen the credibility and visibility of the UTI panel. We see this development as supporting potential test menu expansion for the company’s flagship Unyvero systems in the United States. The market has reacted positively to this news with the stock closing 85% higher in trading.
Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.
.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.