EMA Group Questions Notified Bodies Assessing Companion Diagnostics

The European Medicines Agency should consider whether the EU’s system for assessing companion diagnostic tests is still fit for purpose, according to a report by the EMA’s Genomics, Genetics, Transcriptomics and Epigenetics subgroup.

Experts from Belgium, Germany and the Netherlands cited concerns about notified bodies assessing companion diagnostics, particularly with the rising complexity of genomics tests and their increasing importance in oncology.

Currently, the EMA doesn’t assess companion diagnostics and genetic testing platforms, because that is handled by notified bodies. The report notes that in the U.S., the FDA assesses and approves companion diagnostic and genetic testing platforms.