OpGen - AMR Gene Panel clearance expected shortly
OpGen has announced that it submitted an updated 510(k) summary of its Acuitas AMR Gene Panel test in bacterial isolates to the FDA in June and believes that the review of the 510(k) clearance should be completed by the end of August (a timeline previously communicated to the company by the FDA). That said, given the ongoing pandemic, this timeline is not guaranteed. Also, OpGen continues to plan to initiate a clinical trial program for complicated urinary tract infections (cUTI) with the Unyvero platform in the coming weeks and for invasive joint infections (IJI) later in the year.
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