Oncotype DX® is the only test that predicts
patient's response to chemotherapy
in early stage 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.2, 3, 7, 8
The Recurrence Score® helps provide 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.3, 7, 8
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.
The Oncotype DX® Breast Recurrence Score® test has been developed for patients with early breast cancer, hormone receptor positive (HR+) and HER2 negative, ssw3\w3w3 with the goal of:
The vast majority of patients with HR+, HER2- breast cancer do not benefit from adjuvant chemotherapy.
Chemotherapy may have both short-term and long-term side effects that may affect the health status, quality of life, family and professional life of patients both now and in the future.
Provides insight into tumour biology beyond traditional clinical and pathological features.
The Oncotype DX® Breast Recurrence Score® test analyses the expression of 21 genes and provides information about the risk of distant recurrence and the likelihood of chemotherapy benefit in eligible patients with HR-positive, HER2-negative, early-stage breast cancer.1–6
It is the only multigene assay proven to predict an individual patient’s benefit from chemotherapy.
Extensive clinical research involving more than 85,000 patients has established the clinical validity and utility of the test in patients with HR-positive, HER2-negative, node-negative, early-stage invasive breast cancer.1, 2, 3, 7, 8, 9
The test can therefore help patients and treating physicians make more individualised decisions about whether chemotherapy may be beneficial.2, 3
Supported by robust clinical evidence and recommended by major international guidelines.
The Oncotype DX® Breast Recurrence Score® test has been evaluated in landmark clinical trials, including TAILORx and RxPONDER, and is included in major international clinical guidelines for eligible patients with early-stage HR-positive, HER2-negative breast cancer.3, 5, 6, 10–15
More than two million patients worldwide have used the test to help guide treatment decisions.16
| PROLIFERATION | INVASION | HER2 | OESTROGEN | OTHER | REFERENCE |
|---|---|---|---|---|---|
| Ki-67 | Stromelysin 3 | GRB7 | ER | GSTM1 | Beta-actin |
| STK15 | Cathespin L2 | HER2 | PR | BAG1 | GAPDH |
| Survivin | Bcl2 | CD68 | RPLPO | ||
| Cyclin B1 | SCUBE2 | GUS | |||
| MYBL2 | TFRC |
The test may help identify the majority of eligible patients who may avoid chemotherapy, as well as the smaller proportion of patients who may derive benefit from its addition to endocrine therapy.2, 3
This evidence includes the landmark prospective, randomised TAILORx trial, which enrolled 10,273 patients.3
| <1% ABSOLUTE BENEFIT FROM CHEMOTHERAPY | SIGNIFICANT ABSOLUTE BENEFIT FROM CHEMOTHERAPY |
|---|---|
| 0-25 | 26-100 |
| 80% | 20% |
It has been shown that for 80% of patients there will be no benefit from chemotherapy, while for the remaining 20% chemotherapy may significantly reduce the risk of recurrence.2, 3, 7, 9
Has the new N0 report changed?
Yes. Beginning September 13, 2025, all reports generated from the Exact Sciences® platform for node-negative patients tested with Oncotype DX® will be provided in the updated format.
What are the main reasons for this change?
The node-negative patient reports have been updated to incorporate the most recent 12-year follow-up data from TAILORx and to further refine reporting by patient age. The new report will be stratified by age : ≤50 years and >50 years.
Does the new report look different from the old one?
The same overall template is maintained to ensure consistency and ease of interpretation, while reflecting the updated content.
What is the updated follow-up endpoint for prognosis?
The updated prognostic endpoint is the risk of distant recurrence at 10 years.
How is it determined which age-stratified report will be delivered?
The report type is determined by the patient’s age at the time the test order is placed.
Does the updated report include any new information?
Yes. The report now includes clinical risk information for patients aged ≤50 years with a Recurrence Score® of 16–20 or 21–25.
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.5–6
EFFECTIVE RECURRENCE SCORE®
| 0-25 | 26-100 |
| 85% | 15% |
| NO BENEFIT FROM CHEMOTHERAPY | SIGNIFICANT BENEFIT FROM CHEMOTHERAPY |
A large proportion of patients with positive lymph nodes having the Oncotype DX® test in real-world settings have a Recurrence Score® of 0-17 and would likely be overtreated if they had not undergone the test.17
The Oncotype DX® test is intended to provide additional information to support treatment discussions between patients and their treating physicians. Treatment decisions should be made by the treating healthcare professional based on all relevant clinical information.
Where is the Oncotype DX® breast cancer analysis performed?
Genekor acts as the authorized distributor of the Oncotype DX® test in
Greece. All testing is performed exclusively by Genomic Health, Inc. at its central laboratory in California, United States.
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 8 business days.
What type of sample is required for the Oncotype DX® test?
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).
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.
*For more information on scientific content please contact: scientific.support@genekor.com
*Download the promotional brochure here.
*Download the patient guide here.
1. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817–2826. doi:10.1056/NEJMoa041588.
2. Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726–3734. doi:10.1200/JCO.2005.04.7985.
3. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379(2):111–121. doi:10.1056/NEJMoa1804710.
4. Dowsett M, Cuzick J, Wale C, et al. Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Patients with Breast Cancer Treated with Anastrozole or Tamoxifen: A TransATAC Study. J Clin Oncol. 2010;28:1829–1834. doi:10.1200/JCO.2009.24.4798.
5. Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385(25):2336–2347. doi:10.1056/NEJMoa2108873.
6. Albain KS, Barlow WE, Shak S, et al. Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal Women with Node-Positive, Oestrogen-Receptor-Positive Breast Cancer on Chemotherapy: A Retrospective Analysis of a Randomised Trial. Lancet Oncol. 2010;11:55–65. doi:10.1016/S1470-2045(09)70314-6.
7. Stemmer SM, Steiner M, Rizel S, et al. Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry. npj Breast Cancer. 2017;3:33. doi:10.1038/s41523-017-0034-6.
8. Stemmer SM, Steiner M, Rizel S, et al. Clinical outcomes in ER+ HER2- node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry. NPJ Breast Cancer. 2017;3:32. doi:10.1038/s41523-017-0033-7.
9. Zhang L, Hsieh MC, Petkov V, et al. Trend and survival benefit of Oncotype DX use among female hormone receptor-positive breast cancer patients in 17 SEER registries, 2004-2015. Breast Cancer Res Treat. 2020;180(2):491–501. doi:10.1007/s10549-020-05557-x.
10. Rashmi Kumar N, Schonfeld R, Gradishar WJ, et al. NCCN Guidelines Version 2.2026 Breast Cancer; 2026.
11. Andre F, Ismaila N, Allison KH, et al. Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2022;40:1816–1837. doi:10.1200/JCO.22.00069.
12. Burstein HJ, Curigliano G, Thürlimann B, et al. Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021. Ann Oncol. 2021;32(10):1216–1235. doi:10.1016/j.annonc.2021.06.023.
13. Curigliano G, Burstein HJ, Gnant M, et al. Understanding breast cancer complexity to improve patient outcomes: The St Gallen International Consensus Conference for the Primary Therapy of Individuals with Early Breast Cancer 2023. Ann Oncol. 2023;34(11):970–986. doi:10.1016/j.annonc.2023.08.017.
14. Loibl S, André F, Bachelot T, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2024;35(2):159–182. doi:10.1016/j.annonc.2023.11.016.
15. NICE HealthTech guidance. HTG719. 2024.
16. Exact Sciences. Oncotype DX Breast Recurrence Score® Test Surpasses 2 Million Patients Worldwide. Press release. February 3, 2026.
17. Bello DM, Russell C, McCullough D, et al. Lymph Node Status in Breast Cancer Does Not Predict Tumor Biology. Ann Surg Oncol. 2018;25(10):2884–2889. doi:10.1245/s10434-018-6598-z.