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OpGen Stock Gains On FDA Approval, Interim Q3 Sales

The FDA has granted 510(k) clearance to OpGen Inc’s (NASDAQ:OPGN) Acuitas AMR Gene Panel. The Company is finalizing preparations for its commercial…
byVandana Singh
October 4, 2021
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  • The FDA has granted 510(k) clearance to OpGen Inc’s (NASDAQ:OPGN) Acuitas AMR Gene Panel.
  • The Company is finalizing preparations for its commercial launch in the U.S. in Q4 of 2021.
  • The Acuitas AMR Gene Panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens. 
  • The Acuitas AMR Gene Panel expands the diagnostic capability of clinicians to rapidly and simultaneously test for select drugs in 9 classes of antibiotics.
  • Furthermore, the Company believes that the Acuitas AMR Gene Panel is the first FDA-cleared molecular diagnostic panel that detects a broad panel of AMR markers from isolates.
  • Also, OpGen reported interim Q3 revenue of approximately $1.2 million, up from $1.1 million a year ago.
  • Cash was approximately $25.4 million.
  • Related content: Benzinga’s Full FDA Calendar.
  • Price Action: OPGN stock is up 26.1% at $3.48 during the premarket session on the last check Monday.
 
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