Backed by Major Guidelines | Oncotype DX Test

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.1-9

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 patients1

Only test strongly recommended for all N0 and postmenopausal N1 patients with ER+, HER2- early breast cancer. Recommendation is irrespective of clinical risk, with high evidence quality2

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Test strongly endorsed for the vast majority of N0 and N1, HR+, HER2- early-stage breast cancer patients, irrespective of grade or menopausal status. TAILORx and RxPONDER cutoffs to guide treatment decisions.3 The 2023 update highlights the need to test premenopausal patients as not all require chemotherapy4

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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 chemotherapy5

2024 update highlights that MGAs add value beyond pathology alone when defining patients for chemotherapy6

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Only test considered likely to predict chemotherapy benefit, therefore providing a cost-effective option in patients with early stage, node-negative, micrometastatic and post-menopausal node-positive (N1) breast cancer7

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Only test with sufficient evidence to guide adjuvant chemotherapy treatment decisions for postmenopausal node-negative and node-positive patients with early-stage invasive breast cancer8,9

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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.
As voted by a clear majority of the St Gallen International Expert Consensus panel

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Oncotype DX inclusion in Major Guidelines and Health Technology Assessment bodies.

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In summary, the guideline recommendations and the clinical validation make the Oncotype DX^® test the preferred choice for your HR+, HER2-, early-stage breast cancer patients. Learn more about the evidence behind the Oncotype DX test in node-negative and node-positive patients:

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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.

Learn more

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References

NCCN Guidelines. Version 4.2023. Available at: https://www.nccn.org/store/login/login.aspx?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer Version 5.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. To view the most recent and complete version of the guideline, go online to National Comprehensive Cancer Network - Home. Accessed May 2025
Andre et al. J Clin Oncol. 2022.
Burstein et al. Ann Oncol. 2021.
Curigliano et al. Ann Oncol. 2023.
Cardoso et al. Ann Oncol. 2019.
Loibl et al. Annals of Oncology 2024.
NICE Diagnostics Guidance DG58. Available at: www.nice.org.uk/guidance/DG58
IQWiG Press Release, September 2018. Available at: https://www.iqwig.de/en/projects/d23-01.html Accessed May 2025
Abschlussbericht D23-01A/B. 2024. 21.10.2024. https://doi.org/10.60584/D23-01B Accessed: May 2025

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Have questions about Oncotype DX^®?

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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.
As voted by a clear majority of the St Gallen International Expert Consensus panel

Inclusion in guidelines

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.

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References

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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.

References

Inclusion in guidelines

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.

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References

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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.

References

The Oncotype DX^® test as standard of care to guide chemotherapy treatment decisions

The Oncotype DX^® test as standard of care to guide chemotherapy treatment decisions