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What is the Oncotype DX® test
and what makes it special?

The Oncotype DX® test is the only multi-gene assay that can predict which patients will and will not benefit from chemotherapy and determine the likelihood that these patients will develop metastases in the future.

Prognosis in patients
with invasive breast
cancer

The Recurrence Score® allows patients and physicians to determine the risk of developing distant metastasis in 10 years in patients with early-stage breast cancer. As a result, as few as 20% of patients will have a high Recurrence Score®, indicating a high likelihood of developing metastases and a high benefit from chemotherapy.

Predicting the benefit
of chemotherapy
to the patient

The Recurrence Score® provides information on which patients may and may not benefit from the addition of adjuvant chemotherapy to their treatment plan. Recent studies have shown that 80% of patients tested with Oncotype DX will have a low Recurrence Score®, do not benefit from chemotherapy and have a low chance of developing metastases.

Oncotype DX Breast Recurrence Score®

The Oncotype DX Breast Recurrence Score® is a genomic test that can help women newly diagnosed with early-stage, hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer understand whether adding chemotherapy to hormone therapy will reduce the risk of cancer recurrence. The Oncotype DX® test analyses the expression of 21 genes related to tumor biology. Because each patient’s tumor is unique, understanding the biology of that particular tumor can help inform individualised treatment decisions.

Who is the Oncotype DX® test for?

The Oncotype DX Breast Recurrence Score® test has been developed for patients with early breast cancer, hormone receptor positive (HR+) and HER2 negative, negative lymph nodes regardless of age, or 1-3 positive lymph nodes in postmenopausal women with the goal of:

  • accurately identifying those patients who will benefit from chemotherapy
  • determining the extent of benefit from chemotherapy
  • determining the possibility of the development of metastases

 

The vast majority of patients with HR+, HER2- breast cancer do not benefit from adjuvant chemotherapy.

 

Chemotherapy has both short-term and long-term side effects that affect the health status, quality of life, family and professional life of patients both now and in the future.

Reasons to take the test

Reasons to take the Oncotype DX® test:

Provides insight into tumor biology not available from traditional means (clinical and pathologic features). Without the Oncotype DX® test, doctors can only estimate how likely a patient’s cancer is to come back. Furthermore, the Oncotype DX® test provides personalised information about tumor biology and the potential benefit of adding chemotherapy to the treatment plan to minimise the risk of cancer recurrence.

It is the only test that has been shown to predict response to chemotherapy in early breast cancer Several studies including more than 85,000 patients have consistently demonstrated that only the Oncotype DX® test can predict whether patients will benefit from chemotherapy or not. Therefore, Oncotype DX® test can help patient and treating physician design an individualised treatment plan, because it is clear that most patients with early-stage breast cancer do not benefit from adding chemotherapy to their treatment plan.

Learn more about the difference between predictive and prognostic tests.

See the difference:

Prediction of benefit from chemotherapy, based on prospective clinical studies, makes the Oncotype DX® test unique

It is supported by robust data and has been incorporated into all international guidelines for the treatment of breast cancer. The Oncotype DX® assay has been validated in several clinical studies and over a million people have used it worldwide. It is incorporated into all major guidelines for the treatment of breast cancer, including St. Gallen International Breast Cancer Consensus and the European Society for Medical Oncology (ESMO), as well as the American Society of Clinical Oncology (ASCO®) and the National Comprehensive Cancer Network (NCCN®) in the USA. In addition, major health technology assessment bodies such as the National Institute for Health and Care Excellence (NICE) in the UK and the German Institute for Quality and Efficiency in Healthcare (IQWiG) have recognised the unique value of the Oncotype DX® test.

21 Genes Panel

PROLIFERATIONINVASIONHER2OESTROGENOTHER REFERENCE
Ki-67Stromelysin 3GRB7ERGSTM1Beta-actin
STK15Cathespin L2HER2PRBAG1GAPDH
SurvivinBcl2CD68RPLPO
Cyclin B1SCUBE2GUS
MYBL2TFRC

The Oncotype DX® test for patients with negative lymph nodes

In studies involving > 85,000 patients with HR+, HER2- lymph node-negative early breast cancer, the Oncotype DX® test has been shown to consistently identify the vast majority of patients (80%) who can avoid chemotherapy and the significant minority (20%) of those who will benefit from it. These studies include the largest prospective, randomised clinical trial of adjuvant chemotherapy for breast cancer to date, the landmark TAILORx study, in which more than 10,000 patients participated.

Absolute benefit from chemotherapy

<1% ABSOLUTE BENEFIT FROM CHEMOTHERAPY26% ABSOLUTE BENEFIT FROM CHEMOTHERAPY
0-2526-100
80%20%

It has been shown that for 80% of patients there will be no benefit from chemotherapy, while for the remaining 20% chemotherapy can be lifesaving.

The Oncotype DX® test for patients with 1-3 positive lymph nodes

The Oncotype DX Breast Recurrence Score is predictive of chemotherapy benefit for postmenopausal early breast cancer patients with HR+, HER2- and 1-3 positive lymph nodes. Data from the SWOG-8814 and RxPONDER clinical studies show that a very significant proportion of these patients can safely avoid chemotherapy.

EFFECTIVE RECURRENCE SCORE

0-2526-100
85%15%
NO BENEFIT FROM CHEMOTHERAPYSIGNIFICANT BENEFIT FROM CHEMOTHERAPY

A large proportion of patients with positive lymph nodes having the OncotypeDX® test in real-world settings have a Recurrence Score® of 0-17 and would likely be overtreated if they had not undergone the test

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Frequently Asked Questions

Where is the Oncotype DX® breast cancer analysis performed?

ODX analysis is performed at Genomic Health Inc.’s central laboratories in California, USA.

Is the test covered by my insurance?

For information regarding incurance coverage please contact us at: +30 210 6032138.

In how many days will my results be available?

Results are available within 10 business days.

Paraffin-embedded tumor tissue that has already been removed during surgery.

Paraffin-embedded tumor tissue that has already been removed during surgery.

How do I make the payment for the test?

Payment can be made by bank transfer or debit/credit card.

How should I send my sample?

Genekor is responsible for all necessary procedures for the collection and return of the patient’s sample. You can contact us at: (Local representative phone/email).

How will I receive my results?

The results are shared with your doctor via email. If you need help collecting your sample please contact us at: (local representative phone/email).

How to order the test?

Our Customer Service Team is committed to answer your questions with regards to the services offered by Genekor. If you would like to order any of the tests that Genekor performs please contact us directly.

 

*To complete the test, you are required to complete and send the Consent form that you will find on the link below.

To send your sample, please contact us to arrange all the procedures.
CONTACT

*For more information on scientific content please contact: scientific.support@genekor.com

*Download the promotional brochure here.

*Download the patient guide here.

*Order in the United Arab Emirates here.