- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Sparano JA, Crager MR, Tang G, et al. Development and validation of a tool integrating the 21-gene recurrence score and clinical-pathological features to individualize prognosis and prediction of chemotherapy benefit in early breast cancer. J Clin Oncol. 2021;39(6):557-564.
- Sparano JA, Crager M, Gray RJ, et al. Clinical and genomic risk for late breast cancer recurrence and survival. NEJM Evid. 2024;3(8):EVIDoa2300267.
- Sparano JA, Crager M, Gray RJ, et al. Update of RSClin tool with extended TAILORx follow-up and development and validation of a new tool for risk of late distant recurrence. Presented at: SABCS 2023; December 5-9, 2023; San Antonio, TX. Abstract PO1-02-02.
- Pusztai L, Hoag JR, Albain KS, et al. Development and validation of the RSClinN+ Tool to predict prognosis and chemotherapy benefit for hormone receptor-positive, node-positive breast cancer. J Clin Oncol. 2025;43(8):919-928.
- Kalinsky K, et al. Updated results from a phase 3 randomized clinical trial in participants (pts) with 1-3 positive lymph nodes, hormone receptor-positive (HR+) and HER2-negative breast cancer with recurrence score of 25 or less: SWOG S1007. Presented at SABCS, Dec. 2021; Abstract GS2-07.
- Data on file as of 09/06/2025 at Genomic Health, Inc.
- These tools are intended to assist healthcare professionals (HCPs) by providing individualized risk estimates to help support treatment decisions for patients with HR+, HER2−, node-negative and node-positive (1-3 positive nodes), early-stage invasive breast cancer diagnosis. They are not medical devices and have not been reviewed, cleared, or approved by the FDA. The tools, used at the physician’s discretion, offer individualized risk estimates based on clinical trial data summarized in published literature, providing information that supports clinical decision-making but does not replace or direct the HCP's judgment.
The tools integrate clinical and pathological information with Oncotype DX Breast Recurrence Score® test results to generate individualized risk estimates intended to help inform, but not determine, clinical decisions. They are provided exclusively to HCPs as part of the laboratory-developed test (LDT) offering. HCPs must independently review and interpret the information, considering patient-specific factors, clinical guidelines, and their own professional judgment before making any medical decisions.
Oncotype DX, 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.
