Am I Eligible for the Test?

The Oncotype DX Breast Recurrence Score® test has been validated in multiple clinical trials and is recommended by the UK’s National Institute for Health and Care Excellence (NICE)1 which provides national guidance and advice to improve health and social care in England and Wales. With use in over 1 million people worldwide, the test has also been incorporated into all major international guidelines for clinical practice and treatment in breast cancer.2-6

The Oncotype DX Breast Recurrence Score® test is a genomic test performed on the tumour tissue removed from your breast either when you have a biopsy or you have surgery which means no additional procedure is needed.


Eligibility

You may be a candidate for the Oncotype DX® test if you:

are newly diagnosed with early-stage invasive breast cancer: stage I, II and in some cases of stage III (See glossary);

have cancer that is Hormone (oestrogen and/or progesterone) Receptor-positive (HR+/ER+);

have cells that are Human Epidermal growth factor Receptor 2-negative (HER2-);

are either lymph node negative, 1–3 lymph node positive or have micrometastases (See glossary) in the lymph nodes.


If eligible, why should I have the test?

The Oncotype DX test provides insight into your tumour biology that is not available from traditional measures. More specifically, you and your doctor will receive individualised information as to whether adding chemotherapy to hormone therapy may reduce the risk the cancer returns. Without this test, doctors can only estimate how likely a patient’s cancer is to return by looking at factors such as age, tumour size, tumour grade, and lymph node status.

It is important that that your tumour tissue sample be tested before you start any treatment (hormone therapy or chemotherapy). Talk to your doctor and assess whether you are eligible for testing with the Oncotype DX Breast Recurrence Score test.


The decision of chemotherapy

Chemotherapy can be a life-saving treatment however it comes with many short and long-term side effects7. Consequently, the decision to receive chemotherapy can be difficult for many breast cancer patients and it must be discussed and considered carefully with your doctor.

The Oncotype DX Breast Recurrence Score® test provides your Recurrence Score® result, which is a number between 0 and 100, specific to your tumour. This will help in discussions you will have with your healthcare professional about the need for chemotherapy treatment.


Availability of the Oncotype DX® test in UK health services


The Oncotype DX test® is available for patients treated in the NHS and it is also reimbursed by all major insurance companies for all patients with ER+, HER2- early stage, invasive breast cancer both lymph node negative and lymph node positive 1-3 positive nodes.


With the Oncotype DX test®, you and your doctor can better understand what treatment options are right for you and avoid overtreatment with aggressive therapies like chemotherapy. If you think you are a candidate, don’t hesitate to speak to your doctor about the possibility of having the test.

REFERENCES
  1. NCCN Guidelines Insights: Breast Cancer, version 3.2021
    https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf (accessed Nov. 2021). 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
  2. NICE Diagnostics Guidance DG34 December 2018. https://www.nice.org.uk/ (accessed Nov. 2021).
  3. IQWIG Press Release, September 2018.
  4. Burstein et al. Ann Oncol. 2021.
  5. Andre et al. J Clin Oncol. 2019.
  6. Cardoso et al. Ann Oncol. 2019.
  7. https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/side-effects/side-effects-chemotherapy (accessed Nov. 2021).
  8. Partridge et al. J Natl Cancer Inst Monogr. 2001.
  9. Tao et al. Breast. 2015.
  10. Kim et al. Breast Cancer Res Treat. 2017.
  11. Friese et al. Cancer. 2017.
  12. Drolet et al. CMAJ. 2005.
  13. Breast cancer and labour force re-entry: the Canadian Breast Cancer Network 2010.
  14. Paik et al. J Clin Oncol. 2006.
  15. Albain et al. Lancet Oncol. 2010.
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In the US and certain other jurisdictions, Genomic Health, Oncotype DX, Oncotype IQ, Recurrence Score, Oncotype DX Breast Recurrence Score, Oncotype DX Colon Recurrence Score, Oncotype DX Genomic Prostate Score, and Oncotype DX AR-V7 Nucleus Detect are registered trademarks, and "Making cancer care smarter" and GPS are pending registered trademarks, of Genomic Health, Inc., an Exact Sciences corporation.
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