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OpGen Submits Antibiotic Resistance Test to FDA

NEW YORK (GenomeWeb) — OpGen said today that it has submitted its Acuitas AMR Gene Panel for the detection of antibiotic resistance to the US Food and Drug Administration for 510(k) clearance.

The PCR-based test is designed to detect 47 antibiotic resistance genes in less than three hours from bacterial isolates. It is currently available for research use only.

"The Acuitas AMR Gene Panel test for isolates provides actionable information to help guide physician decision making for critical care patients with acute infections," OpGen Chairman and CEO Evan Jones said in a statement.

Gaithersburg, Maryland-based OpGen said that it is also conducting clinical trials of a direct-from-urine Acuitas AMR Gene Panel and its Acuitas Lighthouse software, which is designed for antibiotic resistance prediction direct from clinical samples and management of antimicrobial resistance data in healthcare institutions. The studies are using samples collected from patients with urinary tract infections.

In March, OpGen closed a $5.4 million public offering, providing funds to support its regulatory and commercial activities, among other things.

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