NEW YORK – OpGen on Monday announced that its Acuitas AMR Gene Panel received 510(k) clearance from the US Food and Drug Administration.
It also said that its preliminary third quarter revenues grew 9 percent year over year.
The Acuitas AMR Gene Panel is a PCR-based test that detects 28 genetic antimicrobial resistance markers in isolated bacterial colonies from 26 different pathogens in less than three hours. It allows clinicians to simultaneously test for select drugs in nine classes of antibiotics to help identify potentially antimicrobial-resistant organisms that could otherwise escape detection, the firm said.
OpGen CEO Oliver Schacht said in a statement that the company expects the clearance of the panel "will expand the total addressable market for this product in the US."
He added that "it will provide us with substantial opportunities to grow our business in detecting AMR in life-threatening infections since rapid detection of antimicrobial resistance in both surveillance and diagnostic settings is still a major challenge for the clinical lab."
The firm is preparing to launch the test in the US in Q4 2021. OpGen first submitted the test to the FDA in May 2019.
In June, Rockville, Maryland-based OpGen said it had submitted an updated 510(k) summary document to the agency, which included changes to documents such as the package insert, electronic user guide, and operator manual.
Separately, the firm reported Monday that its revenues for the third quarter were approximately $1.2 million, up 9 percent from $1.1 million in Q3 2020. As of Sept. 30, the firm had approximately $25.4 million in cash.