Journal: Future oncology (London, England)
This publication reviews the integration of genomic tests, specifically the Oncotype DX Breast Recurrence Score® test, into routine breast cancer care in Europe.
It highlights the test’s role in enabling personalized treatment decisions that improve outcomes while reducing overtreatment and undertreatment.
Despite proven cost-effectiveness, widespread adoption faces four main challenges:
- Evolving regulatory requirements under the EU In Vitro Diagnostics Regulation (IVDR)
- Varied health technology assessment (HTA) frameworks
- Inconsistent reimbursement policies across countries
- Insufficient real-world evidence, particularly for diverse patient populations
The paper emphasizes that while IVDR will standardize regulatory criteria, harmonizing evidence standards for HTA and reimbursement remains critical for broader clinical implementation.