Curetis Unyvero System, Lower Respiratory Tract Infection Cartridge Get FDA Clearance

NEW YORK (GenomeWeb) – German firm Curetis has been granted de novo clearance by the US Food and Drug Administration for a multiplex assay to detect lower respiratory tract infections, as well as for the firm's molecular diagnostic platform, Unyvero. The assay is the first multiplex lower respiratory tract infection test to be cleared by the FDA, the firm noted in a statement.