For providers
Oncotype DX Breast Recurrence Score® Test

Guidance to help inform treatment decisions 

The Oncotype DX Breast Recurrence Score test provides personalized genomic insights for patients with early-stage HR+, HER2- breast cancer.1-6
An Exact Sciences lab technician opening a test box.
For patients with HR+, HER2- breast cancer1-6
Sample taken from existing tumor tissue
Aids in treatment decision making
An Exact Sciences lab technician opening a test box.
A lab technician examining a test sample.

The only test proven to predict the likelihood of chemotherapy benefit1,2,8

3 ways this test can help

Supporting you and your patients in making more informed treatment decisions by understanding their unique tumor biology, their risk of recurrence, and the potential magnitude of chemotherapy benefit.1-6

The Breast Recurrence Score® assay

  • Uses your patient’s unique tumor tissue sample3
  • Assesses the expression of 21 genes3
    • 16 cancer-related genes
    • 5 reference genes
  • Uses reverse transcription polymerase chain reaction (RT-PCR) to analyze tumor RNA3
  • Uses tissue obtained at the time of core biopsy or surgical excision7

A comprehensive genomic assessment

  • Includes the estimated risk of distant recurrence with endocrine therapy alone3,6
  • Helps predict the benefit of adding chemotherapy to endocrine therapy1,2

Quantitative single-gene scores

  • Quantitative estrogen receptor (ER) score helps assess the magnitude of hormonal therapy benefit3
  • Provides additional supporting information, such as progesterone receptor (PgR) and HER2 scores3,9
A doctor and nurse talking in front of a computer monitor.
Science you can trust

Backed by a solid body of clinical evidence

5 key validation studies1-5
1.8+ million patients10
Consistent results1-5

Included in major international breast cancer treatment guidelines

The 21-gene assay (Oncotype DX®) is included in leading international oncology guidelines, including those from the National Comprehensive Cancer Network® (NCCN®), the American Society of Clinical Oncology, and the European Society for Medical Oncology (ESMO).8,11-14*

  • The only genomic assay with the highest recommendation in 5 major international guidelines for risk assessment in patients with early-stage breast cancer8,11-14
  • Included as a recommendation in 2 additional guidelines15,16

*National Comprehensive Cancer Network and NCCN are registered trademarks of the National Comprehensive Cancer Network.

A woman holding up a large card displaying her test results.

Not all genomic tests are created equal

The Oncotype DX Breast Recurrence Score test is the only genomic assay proven to be both prognostic of distant recurrence risk and predictive of chemotherapy benefit. No other genomic test or risk assessment tool provides similar predictive insights.1-6, 8
Two women hugging and smiling.

Is your patient eligible?

The Oncotype DX Breast Recurrence Score test is appropriate for patients who are:1-5

  • Recently diagnosed with invasive breast cancer
    • Anatomic stage I, II, or IIIa
    • Hormone receptor-positive (HR+)
    • Human epidermal growth factor receptor 2-negative (HER2-)
    • Node negative (N0) or node positive (N1mic or N1) 
  • Medically eligible for chemotherapy



NOTE: Your patients diagnosed with noninvasive breast cancer, ductal carcinoma in situ (DCIS), may be eligible for the Oncotype DX Breast DCIS Score® test.

The Breast Recurrence Score test is well covered

86% of patients paid $0

91% paid less than $100*

*This calculation includes patients with Medicare, Medicare Advantage, Medicaid, Managed Medicaid, and commercial insurance. Patients with high-deductible plans may receive a bill for most or all the cost of the Breast Recurrence Score test if they have not satisfied their deductible. The numbers cited are based on historical patient billing data from 1/2/2024 to 12/31/2024. Rates of coverage vary by state and region. Exceptions for coverage may apply. Exact Sciences strongly encourages your patient to contact their insurer with questions about Oncotype DX Breast Recurrence Score test coverage.
A doctor seated at a desk looking at his laptop.

Ordering a test for your patients is fast and easy

Order tests, access results, and receive updates through our Provider Hub.

Explore other testing solutions

We offer a range of tests designed to support your breast cancer patients.

Oncotype DX Breast DCIS Score® test

A tumor-tissue early-stage DCIS breast cancer test that shows how likely breast cancer will return and possible radiation benefit
Cancer type:
Breast
Test type:
Treatment guidance
Treatment guidance tests show how likely cancer might come back and/or how beneficial specific treatments might be to help inform care decisions.
Sample type:
Tumor tissue

Have questions?

Call us at 1 866-662-6897.

References

  1. 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.
  2. 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(1):55-65.
  3. 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.
  4. 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.
  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.
  6. 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(11):1829-1834.
  7. Jakubowski DM, Bailey H, Abran J, et al. Molecular characterization of breast cancer needle core biopsy specimens by the 21-gene Breast Recurrence Score test. J Surg Oncol. 2020;122(4):611-618.
  8. Referenced with permission from the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Breast Cancer V.4.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 28, 2025. 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.
  9. Kim C, Tang G, Pogue-Geile KL, et al. Estrogen receptor (ESR1) mRNA expression and benefit from tamoxifen in the treatment and prevention of estrogen receptor-positive breast cancer. J Clin Oncol. 2011;29(31):4160-4167.
  10. Data on file as of January 27, 2025, at Genomic Health, Inc.
  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(16):1816-1837.
  12. AGO Breast Committee. Diagnosis and Treatment of Patients With Early and Advanced Breast Cancer. Version 2024. 1E. Accessed March 31, 2025. https://www.ago-online.de/fileadmin/ago-online/downloads/_leitlinien/kommission_mamma/2024/englisch/Einzeldateien/AGO_2024E_26_Therapy_algorithms.pdf
  13. Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(8):1194-1220.
  14. Hortobagyi GN, Connolly JL, D'Orsi CJ, et al. Breast. In: Amin MB, Edge SB, Greene FL, et al, eds. AJCC Cancer Staging Manual. 8th ed. Springer; 2017:589-636.
  15. National Institute for Health and Care Excellence (NICE) Guidelines. Tumor profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. Published May 9, 2024. March 31, 2025. https://www.nice.org.uk/guidance/dg58
  16. Burstein HJ, Curigliano G, Loibl S, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019;30(10):1541-1557.

Oncotype DX, Oncotype DX Breast DCIS Score, Oncotype DX Breast Recurrence Score, Breast Recurrence Score, and Recurrence Score are registered trademarks of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation. Exact Sciences is a registered trademark of Exact Sciences Corporation. All other trademarks are the properties of their respective owners. 

The Oncotype DX Breast Recurrence Score test was developed, and the performance characteristics validated by Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The Oncotype DX Breast Recurrence Score test is performed at the Genomic Health Redwood City clinical laboratory. Exact Sciences clinical laboratories are accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing. This test has not been cleared or approved by the US Food and Drug Administration or other notified regulatory authority.