Biomarker and Companion Diagnostics-A Review of Medicinal Products Approved by the European Medicines Agency.

ABSTRACT: Background: An increasing number of medicines authorised in Europe recommend or require biomarker-based patient selection. For some of these the use of a companion diagnostic (CDx), a subset of in vitro diagnostics (IVDs), to identify patient populations eligible for a specific medicinal product may be required. The information and recommendations of use of a medicinal product for which a CDx is required is particularly important to healthcare professionals for correct patient identification. Methods: We reviewed the existing information in SmPCs and European Public Assessment Reports (EPARs) of EU medicinal products approved via the centralised procedure at EMA where reference was made to biomarker testing, including by CDx, for patient selection. Results:</

SUBMITTER: Orellana Garcia LP 

PROVIDER: S-EPMC8591033 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature