OpGen Gets FDA Clearance To Market Acuitas AMR Gene Panel - Quick Facts

(RTTNews) - OpGen, Inc. (OPGN) has received FDA 510(k) clearance to market the Acuitas AMR Gene Panel. The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance markers in isolated bacterial colonies from 26 different pathogens. The company targets commercial launch of the Acuitas AMR Gene Panel in the U.S. in the fourth quarter of 2021.

OpGen also reported total preliminary third quarter unaudited revenue of approximately $1.2 million, up from $1.1 million, a year ago. Cash as of September 30, 2021 was approximately $25.4 million.

OpGen expects to announce new CFO once appointment has been formalized.

Shares of OpGen were up 24% in pre-market trade on Monday.