Genomic tests to guide management of breast cancer in Europe: regulation, reimbursement, adoption, and challenges.

The integration of genomic tests such as the Oncotype DX Breast Recurrence Score® test, into routine clinical practice represents a significant advance in personalized breast cancer care. By supporting more tailored therapeutic decisions, these diagnostics can improve patient outcomes, while reducing risks of undertreatment, overtreatment, and associated side effects. Cost-effectiveness has already been demonstrated in numerous publications. However, for widespread adoption across Europe, four principal challenges must be overcome: regulation, technology assessment, reimbursement, and gaps in real-world evidence. Since May 2022, the European Union In Vitro Diagnostics Regulation (IVDR) has updated requirements for demonstrating clinical utility and analytical and scientific validity, creating new barriers for manufacturers regarding primary evidence generation. Variability in health technology assessment (HTA) frameworks and reimbursement mechanisms across countries further complicates adoption. Demonstrating real-world benefits of these technologies requires robust, representative data collections, yet current clinical trial evidence often underrepresents certain patient populations, raising equity concerns. Whilst the IVDR will help standardize regulatory requirements, challenges remain in harmonizing evidence standards for HTA and reimbursement. This review explores these barriers using the Oncotype DX® test as an exemplar. Evidence was drawn from targeted literature searches and reviews of regulatory, reimbursement, and gray literature relevant to European healthcare systems.