OpGen signs distribution agreement with Fisher Healthcare, submits FDA de novo request

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OpGen this week announced it has entered a distribution agreement with Fisher Healthcare, part of Thermo Fisher Scientific, for the distribution of OpGen’s Unyvero A50 molecular diagnostic platform and in vitro diagnostic (IVD) tests for bacterial pneumonia, called Unyvero LRT and LRT BAL, as well as its research-use-only (RUO) test for urinary tract infection, Unyvero UTI.

Under the distribution agreement, Fisher Healthcare will have access to the Unyvero A50 platform and products to distribute and sell to hospitals and laboratories across the U.S.

The Unyvero LRT cartridge for hospitalized patients with suspected pneumonia is a U.S. Food and Drug Administration (FDA)-cleared IVD product specifically targeting bacterial pneumonia and antimicrobial resistance markers. Meanwhile, the Unyvero UTI product is available as an RUO test to laboratories that do their own validation. The Unyvero UTI panel simultaneously identifies a comprehensive range of pathogens and antibiotic resistance markers associated with urinary tract infections in less than five hours.

The Unyvero UTI cartridge has recently completed its pivotal clinical trial and OpGen recently submitted a de novo classification request for a test that uses the cartridge to the FDA. The trial consisted of a large multicenter study with more than 1,800 patient samples, OpGen said this week in a separate announcement. The primary endpoint for Unyvero UTI for urinary tract infection was successfully met and showed overall weighted average sensitivity of 96.8% and overall weighted average specificity of 97.4%, the firm added.

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