OpGen selected to participate in AMR surveillance initiative during Q3
OpGen continues to make commercial progress with the Acuitas AMR Gene Panel and the Acuitas Lighthouse Software Research Use Only products. During the third quarter we were selected to participate in a ground-breaking antimicrobial resistance surveillance initiative across New York State. As part of the collaboration, OpGen will receive a $1.5M contract for the 12-month demonstration portion of the project, with the potential for full implementation during the next four years, should certain milestones be achieved by all parties involved.The company has commenced performance testing for its Investigational Use Only Acuitas AMR Gene Panel u5.47 test to support a 510 submission to the U.S. Food and Drug Administration. Interactions with the FDA continue under the Agency's Q-Sub process to continue to clarify specific requirements for clinical validation and clinical trials for the Acuitas AMR Gene Panel Tests and the Acuitas Lighthouse Software. The company is targeting its first 510submission for the end of the fourth quarter of 2018 or in the first quarter of 2019. The overall performance testing schedules at OpGen and at third-party sites have been impacted by expanded FDA clinical validation testing requirements and delays in sourcing scale-up quantities of a key reagent for AMR Gene Panel test kits.