Curetis AG has announced the enrollment of the first patient in the prospective phase of its Unyvero U.S. FDA trial.
The primary endpoint of the multicenter U.S. study will be the performance of Curetis’ second generation Unyvero Lower Respiratory Tract (LRT) cartridge, LRT55, in detecting lower respiratory tract infections as compared to microbiology culture – which is currently considered the diagnostic standard of care. In addition, Unyvero results will be compared to an independent molecular composite comparator based on pathogen DNA analysis by PCR and sequencing. At least eight trial sites across the U.S. will participate in the at least 2,500-patient study.
The new trial phase is based on an augmented study design and an enhanced product. This phase of the U.S. trial incorporates two new elements: the latest FDA guidelines for diagnostic trials, and modifications resulting from outcomes of the first phase of this trial. Enrollment completion is anticipated in mid-2016 with FDA submission targeted for the second half of 2016. The Company aims for FDA clearance for Unyvero and subsequent commercialization in early 2017.