ROCKVILLE, Md., June 07, 2021 (GLOBE NEWSWIRE) — OpGen a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, today announced that it has submitted an updated 510(k) summary document to the U.S. FDA for its Acuitas AMR Gene Panel for Isolates. This document incorporates all of the FDA’s requested updates to various key documents such as the Package Insert, Electronic User Guide, and Operator Manual. Consistent with the FDA’s previously communicated timeline, the FDA provided substantive feedback on all of these key documents by the end of May. The FDA previously informed OpGen that it intends to complete its review by the end of August 2021, but that it cannot commit to a timeline and that such timeline can be affected by various factors, including the FDA’s other workload and public health priorities.
Oliver Schacht, CEO of OpGen commented: “We are excited to see the excellent progress that we have been able to make towards completion of our Acuitas AMR Gene Panel for Isolates filings with the FDA and the nice cadence of FDA responses and valuable inputs moving us much closer towards reaching a final FDA clearance decision point in the coming months.”
OpGen recently also completed the move of its U.S. headquarters, laboratories and operations as well as warehouse to its new Rockville, Maryland based facility. The Company plans to register this newly built-out facility with the FDA and other relevant authorities for the future business operations in the U.S. The new 10,000 square feet facility marks the completion of the business integration and will result in net savings of approximately $600 thousand annually in the coming years in terms of operating efficiencies and reduced rent.
Given recent new Unyvero installations in Q1 and 2021 year-to-date as well as anticipated strong demand for additional Unyvero system placements in the upcoming quarters, OpGen has also ordered an additional 30 Unyvero Analyzers from its Curetis subsidiary and will be moving these into its U.S. warehouse facilities in the coming weeks. Going forward, all Unyvero cartridges as well as Acuitas consumables will be stocked and shipped directly from the new Rockville based facility.
About OpGen
OpGen (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGen’s product portfolio includes Unyvero®, Acuitas® AMR Gene Panel and Acuitas® Lighthouse, and the ARES Technology Platform including ARESdb®, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.
For more information, please visit www.opgen.com.
