On 13 December 2022, OpGen (Nasdaq CM: OPGN) announced encouraging top-line 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.
These favorable data should support an FDA De Novo application, which Edison anticipates in Q123, followed by likely launch in 2024, provided FDA clearance is received.
In this video, Edison Group Managing Director, Soo Romanoff and OpGen’s CEO, Oliver Schacht, discuss the significance of the trial data and OpGen’s future plans.
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