OpGen - Unyvero UTI panel approaching final readouts
OpGen has completed patient sample enrollment in its prospective multicenter trial for the Unyvero urinary tract infection (UTI) panel in the United States, taking the company closer to commercializing another Unyvero test panel, following the lower respiratory tract infection (LRT) and the LRT bronchoalveolar lavage tests in 2018 and 2019, respectively. OpGen reported that more than 1,800 samples have been collected across four sites in the United States as part of the study, exceeding the FDA-recommended 1,500 samples. It expects to conclude data analysis in the next couple of months, staying on track for its planned data readout in H2’22. Positive results will be followed by FDA submission, which we expect in H123. We attribute an 80% probability of approval for the panel, which we will reassess once topline data is released.
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