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Company News: Curetis Receives U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge

– First ever multiplex MDx test to be granted clearance by the FDA for this indication
– Commercial launch in the U.S. expected this quarter
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, announced today that the Company has been granted a De Novo clearance by the U.S. Food and Drug Administration (FDA) to market the Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge in the U.S.
