EMA Draft Guideline on Predictive Biomarker Assays Opens Public Consultation to 31 March 2027
November 12, 2026
The European Medicines Agency (EMA) has opened public consultation on a draft guideline on predictive biomarker assays, the laboratory tests that measure the biomarker a medicine is linked to. The Committee for Medicinal Products for Human Use (CHMP) adopted the draft on 3 November 2026. Comments can be submitted from 9 November 2026 until 31 March 2027.
What the draft says about predictive biomarker assays
Predictive biomarker-guided medicines are one of the most widely implemented regulatory concepts of personalised medicine in Europe. The medicine is tied to a biomarker so that treatment can target the patients most likely to benefit in efficacy, safety or both. The draft says this depends on an assay that is analytically robust, reliable and clinically useful. Where the assay meets the IVDR definition, it may be a companion diagnostic (CDx).
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