EMA: Draft qualification opinion on the ingestible sensor system for medication adherence as biomarker for measuring patient adherence to medication in clinical trials

Proteus Digital Health Inc. intends to have its Proteus technology approved as a ‘qualified method’ for measuring adherence to medication in clinical trials by associating relevant physiologic and behavioural parameters, such as indications of therapeutic response. The Proteus technology is an ingestible event marker, a platform technology that can be co-formulated with active pharmaceutical compounds into drug/device combinations, integrating measuring of medication adherence into oral pharmacotherapy. The ingestible event marker is approved for marketing in the European Union and the United States as a medical device.