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About Oncotype DX

Oncotype DX Process
Advantages of RT-PCR
Oncotype DX Development
Oncotype DX Results

The Role of Oncotype DX

Oncotype DX Studies

Oncotype DX Logistics

Clinical Practice Guidelines

Health Insurance Coverage

The TAILORx Clinical Trial

Frequently Asked Questions


Updated NCCN Guidelines

Coming Soon ER and PR Scores

Healthcare Insurance


About Oncotype DX

Oncotype DX ® is a diagnostic assay that quantifies the likelihood of breast cancer recurrence in women with newly diagnosed, early stage breast cancer. In addition to predicting distant disease recurrence, Oncotype DX also assesses the benefit from chemotherapy.1 The assay — performed using formalin-fixed, paraffin-embedded tumor tissue — analyzes the expression of a panel of 21 genes and the results are provided as a Recurrence ScoreTM (0-100). The gene panel was selected and the Recurrence Score calculation was derived through extensive laboratory testing and multiple independent clinical development studies.

Oncotype DX is the only multiparameter gene expression assay found to show clinical utility in breast cancer, as recommended in the ASCO 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer and the NCCN 2008 Clinical Practice Guidelines in Oncology Breast Cancer . 2,3


Oncotype DX is validated for use in breast cancer patients whose disease is:
  • Newly diagnosed
  • Stage I or II
  • Node-negative
  • Estrogen receptor-positive
Oncotype DX now offers clinical experience information for newly diagnosed women who are post-menopausal and have node positive, estrogen receptor positive breast cancer and who will be treated with tamoxifen.4



Invasive Breast Cancer - chart


1 The data on chemotherapy benefit is derived from the NSABP Study B-20 which compared hormonal therapy alone versus CMF based chemotherapy and hormonal therapy.
2 Harris L., Fritsche H., Mennel R., et al; American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer, published ahead of print on October 22, 2007 as 10.1200/JCO.2007.14.2364
3 National Comprehensive Cancer Network 2008 Clinical Practice Guidelines in Oncology, Breast Cancer
4 Albain K, Barlow W, Shak S, Hortobagyi G., et al; Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal, node-positive, ER-positive breast cancer (S8814, INT0100). Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San Antonio, Texas. Abstract #10

What's New?

June 2, 2008
Genomic Health Announces Expansion of Oncotype DX(R) Breast Cancer Test to Include Quantitative Estrogen Receptor (ER) and Progesterone Receptor (PR) Scores

May 31, 2008
Genomic Health Announces Results of Initial Studies to Develop Predictive Tests for Targeted Therapies


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