NEW YORK – OpGen announced Tuesday it has issued a formal response to the US Food and Drug Administration's request for additional information for its Acuitas AMR Gene Panel premarket submission.
OpGen originally submitted 510(k) premarket notification for the test in May 2019, and the FDA has requested additional information twice: once in July 2019, and once at the beginning of 2020. OpGen's response to the 2020 request was delayed in June due to the COVID-19 pandemic. The PCR-based test detects 47 antibiotic resistance genes in less than three hours from bacterial isolates.
The company said in a statement it has been working with the FDA's review team to address the outstanding questions and open items. OpGen COO Johannes Bacher added the firm is waiting on final feedback from FDA and "a swift FDA clearance decision in the coming weeks."
The Acuitas AMR Gene Panel is currently being used for testing isolates in a collaboration project with the New York State Department of Health. In June, the partnership was expanded after first-year milestones were reached.