Approved medicinal products with potential companion diagnostic tests : An Inventory of the Swedish/European drug market

Sammanfattning: The newly introduced regulation (EU) 2017/746 aims to make In Vitro Diagnostic Medical Devices (IVDMD), which include companion diagnostic tests (CDx), a widespread method of authorising medicinal products in the European market. However, European SmPCs (Summary of Product Characteristics) currently do not explicitly refer to the term or classify tests associated with medicinal products as CDx. This paper is the first to examine and classify tests for medicinal products currently authorised in Sweden as being potential CDx, under the definitions of the new regulatory paradigm. The aim is to serve as the foundation for future research. 141 medicinal products with potential associated CDx are identified in the database of the Swedish Medical Products Agency (MPA). These products are then classified under the major ATC (Anatomical Therapeutic Chemical) therapeutic areas to search for commonalities and patterns in their usage and are later examined in conjunction with the techniques they use. The results reveal that a majority are concentrated in the Antineoplastic and immunomodulating agents and Antiinfectives for systemic use therapeutic areas. The methods used by these tests reveal diversity among the test technique usage, including instances where multiple techniques comprise a single CDx product, which may focus on detecting several biomarkers.