Wednesday, April 19, 2023
OpGen, Inc., a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that the Company has entered into a non-exclusive distribution agreement with Fisher Healthcare, a part of Thermo Fisher Scientific. The agreement is for the distribution of OpGen’s Unyvero A50 platform and in vitro diagnostic (IVD) tests for bacterial pneumonia (Unyvero LRT and LRT BAL) as well as its research use only (RUO) test for urinary tract infection (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 antimicrobial resistance markers. The Unyvero UTI cartridge has recently completed its pivotal clinical trial and OpGen has recently submitted a De Novo classification request for Unyvero UTI to the FDA. The Unyvero UTI product is available as a RUO test to laboratories that do their own validation.
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 United States.
Oliver Schacht, Chief Executive Officer of OpGen, commented, “We are very excited about the strategic distribution partnership with Fisher Healthcare as we believe the partnership will increase our Unyvero platform’s commercial presence and footprint across the U.S. We view this expansion in our commercial channel strategy as the next step towards driving commercial adoption of Unyvero in the U.S. and achieving our revenue growth objectives in the coming years.”