OpGen

Under the terms of the agreement, OpGen would sell $10 million in stock and warrants to a US-based healthcare-focused institutional investor.

The firm beat the consensus Wall Street estimate on the top line but fell short of the estimate on the bottom line.

News items for the in vitro diagnostics industry for the week of Oct. 26, 2020.

Following its recent acquisition of Curetis, OpGen has also shifted its focus onto its Unyvero molecular diagnostics platform and bioinformatics operations.

The company first submitted for 510(k) clearance last year and has received two additional information requests from the agency.

The project, coordinated by Jena University Hospital and expected to run for five years, aims to address resistance mechanisms in Gram-negative pathogens.

The firm had been distributing BGI's SARS-CoV-2 test kit but will stop distributing it effective immediately, OpGen's CEO said.

A partnership with Menarini Silicon Biosystems to market Menarini’s portfolio of COVID-19 related products was among its key quarterly milestones.

The firm said it expects FDA clearance for its Acuitas AMR Gene Panel, although it has been delayed due to the agency's extended review timelines.