OpGen reports Q1 EPS (41c), consensus (31c)
Reports Q1 revenue $1.02M, consensus $1.1M. "We have achieved several critical milestones to start the year, led by the submission of our first FDA 510(k) application for testing of antimicrobial resistance genes in bacterial isolates. We expect the process with the FDA to be completed in 2019 and have already started preparing for this key product launch," said Evan Jones, chairman and CEO of OpGen. "Simultaneously, we are working to complete two additional 510(k) submissions for our lead rapid molecular diagnostic test, the Acuitas AMR Gene Panel (Urine) and the Acuitas Lighthouse Software. The clinical trials to support these submissions are anticipated to begin by the end of the second quarter. We plan to complete these trials in the third quarter of 2019 and will prepare the 510(k) submissions shortly thereafter."