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OpGen, Fisher Healthcare Ink Distribution Deal for Unyvero MDx System

NEW YORK – OpGen announced on Tuesday that it has entered into a distribution partnership for its Unyvero A50 system and in vitro diagnostic tests with Fisher Healthcare, a division of Thermo Fisher Scientific. Financial terms of the deal were not disclosed.

Under the partnership, Fisher Healthcare will become the nonexclusive national laboratory distributor alongside OpGen's direct US sales force for the Unyvero A50 platform and accompanying highly multiplexed PCR assays.

The initial focus of the partnership will be US Food and Drug Administration-cleared assays for lower respiratory tract infections called the Unyvero LRT cartridges for hospitalized pneumonia patients and research-use-only urinary tract infection tests called Unyvero UTI.

The Unyvero LRT cartridge for hospitalized patients with suspected pneumonia is the first ever FDA-cleared IVD product specifically targeting bacterial pneumonia and genotypic antimicrobial resistance markers, OpGen said in a statement. The Unyvero UTI cartridge, meanwhile, has recently completed its clinical trial, and OpGen has submitted a de novo classification request for Unyvero UTI to the FDA. The product is available as a RUO test to laboratories that do their own validation, the firm said in a statement.

Oliver Schacht, CEO of OpGen, said in a statement that the firm expects the partnership to increase Unyvero's commercial presence and footprint across the US. "We view this expansion in our commercial channel strategy as the next step towards driving commercial adoption of Unyvero in the US and achieving our revenue growth objectives in the coming years," Schacht said.