Randox Laboratories announced that the U.S. Food and Drug Administration (FDA) has approved the De Novo application for the company’s first Companion Diagnostic (CDx). This is a major achievement for Randox following over 3 years of innovative development and collaboration with Novo Nordisk. The Companion Diagnostic was developed as a new option for determining the amount of medication a patient with hemophilia has received.

Precision BioLogic said Thursday it secured US Food and Drug Administration 510(k) premarket clearance for its Cryocheck Chromogenic Factor IX test for managing hemophilia B.