The Oncotype DX® test as standard of care to guide chemotherapy treatment decisions
The Oncotype DX test has clear recommendation from major international guidelines and several key European Health technology assessment bodies.
Due to the comprehensive dataset of the Oncotype DX Breast Recurrence Score® test, guidelines and HTA body recommendations position the Oncotype DX test as the preferred multigene assay.
All recommendations have been updated after the publication of the two major clinical trials TAILORx and RxPONDER.
The trials looked at different patient populations, node-negative and node-positive respectively. As a result, some recommendations are classified by nodal status to reflect the wealth of data available.
Below is a high-level overview of each of the major guidelines and HTA bodies worldwide.
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Only assay recognized by NCCN Guidelines® to predict adjuvant chemotherapy benefit and the only assay classified as the “preferred” test in both N0 and postmenopausal N1 patients. In addition, guidelines recommend to “consider” the Oncotype DX test for premenopausal N1 patients
May be used to gain additional prognostic and/or predictive information with 1A evidence to complement pathology assessment and to predict the benefit of adjuvant chemotherapy
2024 update highlights that MGAs add value beyond pathology alone when defining patients for chemotherapy
- National Comprehensive Cancer Network® (NCCN®) are registered trademarks of NCCN. ASCO and ESMO are trademarks of the American Society of Clinical Oncology and European Society for Medical Oncology, respectively. NCCN, National Institute for Health and Care Excellence (NICE), St Gallen International Consensus Panel, ASCO and ESMO do not endorse any product or therapy.
- National Institute for Health and Care Excellence (NICE) Diagnostics Guidance DG58, December 2018.
www.nice.org.uk/guidance/dg58 (Accessed May 2025). All rights reserved. Subject to Notice of rights NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Node-negative clinical evidence
The clinical validity and utility of the Oncotype DX Breast Recurrence Score test in patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer have been established through extensive clinical research in over 85,000 patients.
Node-positive clinical evidence
The Recurrence Score® result has been proven to be predictive of chemotherapy benefit for HR+, HER2-, node-positive postmenopausal patients in the retrospective SWOG-8814 study.
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