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Randox Laboratories

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Randox Laboratories

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FDA approves the Randox ConcizuTrace™ ELISA Companion Diagnostic (CDx)

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.

4 June 2025

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