The European Medicines Agency has issued final guidance outlining the procedure that notified bodies designated to review in vitro diagnostics (IVDs) must follow when seeking a scientific opinion on the suitability of a companion diagnostic (CDx) with the concerned medicinal product.
The guideline is expected to further support the development of CDxs or biomarkers that are a critical tool for furthering personalized medicine as they can help match a patient to a specific drug or therapy by predicting a likely response or severe toxicity
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