Breast cancer test kit Oncotype DX Breast Recurrence Score®

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Product overview
The Oncotype DX Breast Recurrence Score® test is a genomic assay performed on formalin-fixed, paraffin-embedded (FFPE) tumor tissue to estimate risk of distant recurrence and to help predict the potential benefit of adding chemotherapy to endocrine therapy in patients with hormone receptor–positive (HR+), HER2‑negative early-stage breast cancer.

How the Breast Recurrence Score assay works

• Analyzes a patient-specific tumor sample obtained from core biopsy or surgical excision
• Measures expression of a 21‑gene panel
  • 16 cancer-related genes
  • 5 reference genes
• Employs reverse transcriptase–polymerase chain reaction (RT‑PCR) on extracted tumor RNA

Provides a genomic assessment

• Generates a Recurrence Score estimating the risk of distant recurrence with endocrine therapy alone
• Supports clinical decision-making by predicting the likely benefit of adding chemotherapy to endocrine therapy

Determines quantitative single-gene scores

• Reports a quantitative estrogen receptor (ER) score to inform magnitude of endocrine therapy benefit
• Provides supporting quantitative scores for progesterone receptor (PR) and HER2

Clinical and laboratory information

• Performed at the Genomic Health Redwood City clinical laboratory (Genomic Health, Inc., a wholly‑owned subsidiary of Exact Sciences Corporation)
• Exact Sciences clinical laboratories are College of American Pathologists (CAP) accredited and CLIA certified for high‑complexity clinical testing
• Test has not been cleared or approved by the US Food and Drug Administration or other notified regulatory authority

Key references and clinical evidence

• 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.
• 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, estrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55-65.
• 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.
• 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.
• Kalinsky K, et al. Updated results from a phase 3 randomized clinical trial in participants 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.
• 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.
• 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.
• 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.
• Badve S, et al. Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry and Reverse-Transcription Polymerase Chain Reaction. J Clin Oncol. 2008;26(15):2473–2481.
• Baehner FL, et al. Quantitative RT-PCR analysis of ER, PR, and HER2 expression in FFPE tumor tissue: Comparison with IHC and FISH. J Clin Oncol. 2010;28(15_suppl):10572.

Technical characteristics / specifications

• Test type: Genomic assay on FFPE tumor tissue using RT‑PCR
• Genes analyzed: 21‑gene panel (16 cancer-related genes + 5 reference genes)
• Sample source: Core biopsy or surgical excision tissue (FFPE)
• Clinical outputs: Recurrence Score estimating distant recurrence risk and prediction of chemotherapy benefit; quantitative single‑gene scores for ER, PR and HER2
• Intended population: Patients with HR+, HER2‑ early-stage breast cancer (regardless of nodal status)
• Laboratory: Performed at Genomic Health Redwood City clinical laboratory; CAP accredited, CLIA certified
• Regulatory status: Not cleared or approved by the US FDA