What is the Oncotype DX Breast Cancer Test?

Because not all women benefit from chemotherapy equally, the Oncotype DX assay is a 21-gene assay that provides an individualized prediction of chemotherapy benefit and 10-year distant recurrence to inform adjuvant treatment decisions in certain women with early-stage invasive breast cancer1,2. The Oncotype DX Recurrence Score® result cannot be predicted by traditional clinicopathologic variables1, and provides critical information that changes treatment decisions approximately 37% of the time3.

Even when treatment decisions based on traditional measures seem conclusive, the Oncotype DX assay can lead to a different approach

The Oncotype DX Assay:

  • Provides an individualized Recurrence Score result that cannot be predicted by traditional clinicopathologic variables1
  • Is the only assay incorporated into NCCN®, ASCO®, and St Gallen clinical practice guidelines4-6
  • Is the first commercial multigene expression assay to predict the benefit of chemotherapy in patients with ER-positive, HER2-negative breast cancer7
  • Fulfills the criteria for National Cancer Institute Level I, Category B evidence, with consistent results in more than one prospective validation study using archived samples8
  • Has been clinically validated in 13 studies with over 4,000 breast cancer patients1,2,9-19
  • Can spare patients the negative health and quality of life impact of unnecessary chemotherapy and result in cost savings3,20-22
  • Has the longest history and track record of commercial genomic assays with over 200,000 patients tested23

Genomic Health is committed to making the Oncotype DX assay available to your patients

Sign up now for the Customer Portal at https://online.genomichealth.com for online ordering and results

Call Customer Service at 866-ONCOTYPE to open an account

Ensuring access to Oncotype DX assay for invasive breast cancer

  • Extensively reimbursed in node-negative disease: more than 95% of privately insured lives and Medicare beneficiaries are covered *Expanding coverage in node-positive patients
  • Provides comprehensive services to ease the reimbursement process for you, your staff, and your patients through the Genomic Access Program (GAP)
  • GAP provides several assistance programs designed to help patients based on financial eligibility

Genomic Health is a CLIA-certified, CAP-accredited reference laboratory

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;24:3726-3734.
2. 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;351:2817-2826.
3. Hornberger J, Chien R. Meta-analysis of the decision impact of the 21-gene breast cancer Recurrence Score® in clinical practice. Presented at: 33rd Annual San Antonio Breast Cancer Symposium; December 8-12, 2010; San Antonio, TX. Poster P2-09-06.
4. National Comprehensive Cancer Network®. NCCN Clinical Practice Guidelines in Oncology™: Breast cancer. Version 2.2011. Available at: www.nccn.org. Accessed September 29, 2011.
5. Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 update of recommendations.
6. Goldhirsch A, Wood W, Coates A, Gelber R, Thürlimann B, Senn H-J, and Panel members. Strategies for subtypes—dealing with the diversity of breast cancer: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2011. Ann Oncol. 2011;22:1736-1747.
7. St Gallen International Breast Cancer Expert Panel Guidelines include Oncotype DX as predictor of chemotherapy benefit [news release]. Geneva, Switzerland and Redwood City, CA: Genomic Health, Inc; July 25, 2011. Available at Genomic Health. Accessed October 3, 2011.
8. Simon R, Paik S, Hayes D. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009;101:1446-1452.
9. Habel L, Shak S, Jacobs M, et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res. 2006;8:R25-R39.
10. 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.
11. Albain K, Barlow W, 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.
12. Paik S, Shak S, Tang G, et al. Expression of the 21 genes in the Recurrence Score assay and tamoxifen clinical benefit in the NSABP study B-14 of node negative, estrogen receptor positive breast cancer. J Clin Oncol. 2005;23(suppl 16S). Abstract 510.
13. Goldstein L, Gray R, Badve S, et al. Prognostic utility of the 21-gene assay in hormone receptor–positive operable breast cancer compared with classical clinicopathologic features. J Clin Oncol. 2008;26:4063-4071.
14. Paik S, Shak S, Tang G, et al. Multi-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients—NSABP studies B-20 and B-14. Presented at: 26th Annual San Antonio Breast Cancer Symposium; December 3-6, 2003; San Antonio, TX. Abstract 16.
15. Esteban J, Baker J, Cronin M, et al. Tumor gene expression and prognosis in breast cancer: multi-gene RT-PCR assay of paraffin-embedded tissue. Presented at: 39th Annual Meeting of the American Society of Clinical Oncology; May 31-June 3, 2003; Chicago, IL. Abstract 3416.
16. Cobleigh M, Tabesh B, Bitterman P, et al. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res. 2005;11:8623-8631.
17. Esteva F, Sahin A, Massimo C, et al. Prognostic role of a multigene reverse transcriptase-PCR assay in patients with node-negative breast cancer not receiving adjuvant systemic therapy. Clin Cancer Res. 2005;11:3315-3319.
18. Gianni L, Zambetti M, Clark K, et al. Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol. 2005;23:7265-7277.
19. Toi M, Iwata H, Yamanaka T, et al. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population. Cancer. 2010;116:3112-3118.
20. Lo S, Norton J, Mumby P, et al. Prospective multicenter study of the impact of the 21-gene Recurrence Score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol. 2010;28:1671-1676.
21. Hornberger J, Cosler L, Lyman G. Economic analysis of targeting chemotherapy using a 21-gene RT-PCR assay in lymph-node–negative, estrogen-receptor–positive, early-stage breast cancer. Am J Manag Care. 2005;11:313-324.
22. Hornberger J, Chien R, Drebs K, Hochheiser L. US insurance program’s experience with a multigene assay for early-stage breast cancer. J Oncol Pract. 2011;7:e38s-e45s.
23. Genomic Health presents ten new studies in breast, colon and prostate cancers at the American Society of Clinical Oncology (ASCO) Annual Meeting [press release]. Chicago, IL: Genomic Health, Inc; June 4, 2011. Available at Genomic Health. Accessed October 3, 2011.
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