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OpGen

The firm provided updates on its bacterial pathogen detection and antimicrobial resistance testing for bacterial isolates and a direct-from-urine test.

The Gaithersburg, Maryland-based company continues to await US Food and Drug Administration clearance for its antimicrobial resistance test.

The company also reported a jump in its first quarter net loss as operating expenses climbed on higher research and development spending.

The PCR-based test is designed to detect 47 antibiotic resistance genes in less than three hours from bacterial isolates to help guide treatment decisions.

Proceeds will be used for the anticipated regulatory submission of its gene panel test for urinary tract infections and drug resistance, among other things.

In an SEC document, the company said net proceeds are expected to be $5.8 million and will be used to support an anticipated submission to the FDA, among other things.

The company has been gearing up to submit its Acuitas AMR Gene Panel product to the US Food and Drug Administration for regulatory clearance.

The company said it expects to submit its Acuitas assay for common causes of urinary tract infections to the US Food and Drug Administration early next year.

OpGen's research-use-only Acuitas AMR Gene Panel u5.47 is designed to detect multidrug-resistant bacterial pathogens in urine or bacterial isolates.

The firm said it will use the net proceeds for R&D, including the continued development of its Acuitas AMR gene panels and Acuitas Lighthouse software.

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