Breast Cancer

*Note: Validation studies have already been performed on the 21-gene Oncotype DX Breast Cancer Assay for N- and N+, ER+ breast cancer; for single gene reporting of quantitative of ER, PR and HER2 genes, and for patients treated with Tamoxifen or an Aromatase Inhibitor. The 21-gene breast cancer assay is currently commercially available. Visit OncotypeDX.com for detailed information.

Oncotype DX 21 Gene Breast Cancer Assay

New Targets DCIS (Ductal Carcinoma In Situ) with original 21 gene assay

Chemotherapy Benefit With Specific Drugs/Drug Classes with potential new genes

DCIS with potential new genes
Development Stage Early development (DCIS 21 genes)

Development (specific chemotherapy response potential new genes)

Early development (DCIS potential new genes)
U.S. Incidence of Breast Cancer1 205,000/Year
U.S. Incidence of DCIS 60,000/Year
Global Incidence of Breast Cancer2 1.3 Million/Year

About Breast Cancer and Genomic Health’s Products in Development

Breast cancer is a cancer that forms in the breast tissue, most often in the lobules (glands where milk is made) or ducts (tubes that carry milk to the nipple). Although most cases of breast cancer occur in women, it can also occur in men. Among women (in both the U.S. and worldwide), breast cancer is by far the most common type of cancer.3

Genomic Health’s Oncotype DX Breast Cancer Assay is a test that examines a woman’s tumor tissue at a molecular level and gives information about her individual disease, including the likelihood that her cancer will recur and the likelihood she would benefit from adjuvant chemotherapy. The assay results have been shown to predict the magnitude of chemotherapy benefit for patients treated with various chemotherapy regimens such as CMF, CAF, doxorubicin-paclitaxel and docetaxel alone, suggesting that the current 21 genes predict the benefit of chemotherapy generally

DCIS (Ductal Carcinoma-In-Situ)

DCIS is an early form of breast cancer that is being diagnosed at an increasing rate, particularly with the adoption of screening mammography. Unlike invasive breast cancer, DCIS has not spread outside of the ducts within the breast. However, women who are diagnosed with DCIS have a risk of recurrence of DCIS or of progression to invasive breast cancer.

Current treatment for DCIS includes surgery, followed in some cases by radiation therapy and/or hormonal therapy. While the benefit of these therapies has been established, it is clear that not all patients benefit equally. Genomic Health tests in development that examine a woman’s tumor tissue at a molecular level and provide information for individual treatment planning for women with invasive breast cancer may also be useful to guide treatment planning in DCIS.

Potential New Genes

Genomic Health is investigating the value of new genes for predicting the benefit of specific chemotherapy drugs or drug classes, such as taxanes, or the benefit of specific targeted biologic therapies. Studies looking at additional genes beyond the current 21 Oncotype DX genes may expand the test’s utility to encompass newer adjuvant breast cancer therapies such as taxanes, as well as ductal carcinoma-in-situ (DCIS).

For more information about breast cancer, visit the National Cancer Institute’s Breast Cancer page or the non-profit organization www.breastcancer.org
  1. Mattson Jack DaVinci ©2004, 2007.
  2. Globocan 2002/ACS Cancer Facts & Figures, 2007.
  3. American Cancer Society 2007 Statistics. Available at: http://www.cancer.org/downloads/STT/CAFF2007PWSecured.pdf. Accessed July 22 2008.
Breast Cancer (New Assays)