Dutch study shows: both clinical and analytical performance are crucial for EMA marketing authorization of CDx.

Companion diagnostics (CDx)must be evaluated by notified bodies since the IVDR comes into force in May 2022. A recent study assessed how the EMA addressed new CDx in 2017-2019 in dossiers for marketing authorization procedures and 2016-2020 in scientific advisory procedures before the implementation of the new IVDR. The analysis reveals that CDx played a role in the evaluation of 20 of 167 medicines approved or rejected by the EMA. Using both the European public assessment reports (EPARs) and the internal assessment reports (ARs) from the EMA's centralized approval process, the authors showed that clinical performance and analytical performance of CDx were the most frequently discussed topics. The experience from the previous assessment processes, may serve as a guide when EMA and EU Member State national agencies are formally consulted by notified bodies on CDx performance and safety.

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