- Primary endpoint for Unyvero LRT product for lower respiratory tract infections shows overall weighted average sensitivity of 90.2% and overall weighted average specificity of 99.3%
- U.S. FDA submission being prepared
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced top line data from its successfully completed Unyvero U.S. FDA trial. The trial was designed to compare the performance of the Unyvero Instrument Platform and the Unyvero LRT Lower Respiratory Tract Cartridge in detecting lower respiratory tract infections to microbiology culture, the current diagnostic standard of care. Additionally, the trial compared Unyvero results to a composite of microbiology and independent PCR tests plus sequencing. The prospective and retrospective study met its primary endpoint by demonstrating an overall weighted average sensitivity of 90.2% and an overall average weighted specificity of 99.3%.