OpGen, Inc. (NASDAQ:OPGN, &ldquo, OpGen&rdquo, ))), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has issued its formal response to the second of the FDA’s AI Requests (Additional Information Request) for the Acuitas AMR Gene Panel pre-market submission, addressing what OpGen believes to be all of the FDA’s questions and open items.
OpGen had submitted a 510(k) Premarket Notification for the Acuitas AMR Gene Panel for Isolates to FDA in May 2019 and had subsequently received two formal AI Requests from the agency; the first in July 2019 and the second in early 2020. While a 180-day response deadline is normally imposed for these requests, the OpGen response was delayed in June 2020 as consequence of the COVID-19 pandemic when all pre-market submissions on hold as of March 2020 were issued a 90-day extension to the previously established response deadlines. During recent weeks and months, OpGen has been working with the FDA review team on an interactive basis to address any and all outstanding information requests and has received numerous inputs and feedback that have all been built into the formal response.
Johannes Bacher, COO of OpGen commented: “With the successful and timely completion of our formal response we are now eagerly awaiting the Agency’s final feedback and hope for a swift FDA clearance decision in the coming weeks. We believe to have a unique panel for a key healthcare threat in antimicrobial resistance with unparalleled comprehensive coverage of genetic AMR markers in the most relevant bacterial pathogens that are of key concern in our hospitals today.”
Oliver Schacht, President and CEO of OpGen added: “The Acuitas AMR Gene Panel is already being used for testing isolates as part of a collaborative research project looking at epidemiological surveillance by various major healthcare facilities in New York State as part of a two-year strategic NY State Department of Health collaboration project. Receiving FDA clearance would allow us to make this available much more broadly across the United States for tracking down and tracing outbreaks of hospital superbugs and prevent them from spreading from one hospital to the next.”