Backed by Major Guidelines | Oncotype DX® Test

Recommended in all major international guidelines

Based on the comprehensive dataset of the Oncotype DX Breast Recurence Score test, guidelines and HTA body recommendations position the Oncotype DX test as the preferred multigene assay^1-8.

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

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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 quality⁵

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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.⁴

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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 chemotherapy⁶

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Only test considered to predict chemotherapy benefit, therefore providing a cost-effective option in patients with early-stage, node-negative and micrometastatic breast cancer³

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The Oncotype DX Breast Recurrence Score^® test is included in the AJCC breast cancer staging criteria and may be used to assign prognostic stage group. Stage IB and stage IIA early stage node-negative breast cancer patients can downstage to stage IA with Recurrence Score^® results <11.

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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, 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 DG34, December 2018. www.nice.org.uk/guidance/dg34 (6 Feb 2020). 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
AJCC is a trademark of the American College of Surgeons. AJCC does not endorse any product or therapy.

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

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Node-negative clinical evidence

Node-positive clinical evidence

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References

NCCN Guidelines. 3.2022. 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 V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 24, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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.
NICE 2018. Available at: https://www.nice.org.uk/guidance/DG34/chapter/1-recommendations Accessed: May 24, 2022
IQWiG Press Release, September 2018. Available at: https://www.iqwig.de/en/press/press-releases/biomarker-tests-in-breast-cancer-new-study-data-indicate-advantage-for-certain-patients.10059.html Accessed: May 24, 2022
AJCC Cancer Staging Manual, Eighth Edition, updated 9-Nov-17.

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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, 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 DG34, December 2018. www.nice.org.uk/guidance/dg34 (6 Feb 2020). 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
AJCC is a trademark of the American College of Surgeons. AJCC does not endorse any product or therapy.

Inclusion in guidelines

Recommended in all major international guidelines

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References

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References

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