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Oncotype DX


Oncotype DX, is a commercial diagnostic test that estimates the likelihood of disease recurrence in women with early-stage hormone estrogen receptor (ER) positive only breast cancer (prognostic significance). It remains unproven whether the test also provides information about the likely benefit from chemotherapy (predictive significance).

Oncotype DX analyzes the expression of a panel of 21 genes within a tumor to determine a Recurrence Score. The Recurrence Score is a number between 0 and 100 that corresponds to one of three risk categories with a specific likelihood of breast cancer recurrence within 10 years of the initial diagnosis. The score itself is not validated, though the buckets of Low, Intermediate or High Risk are, assuming the patient receives at least 5 years of Tamoxifen therapy. With this information, it may be possible for doctors and patients to make more informed decisions about breast cancer treatment options. Oncotype DX is performed by Genomic Health in its CLIA-certified, CAP-accredited reference laboratory.

The test was initially developed for women with early-stage invasive breast cancer with ER+ cancers whose lymph nodes do not contain tumor (node-negative). Typically in these cases, treatment with anti-hormonal therapy, such as tamoxifen or aromatase inhibitors, is planned, and the test can help define whether chemotherapy should or should not be added to that anti-hormone treatment.


The current list price of Oncotype DX is $4,175.00. Several studies indicate that the use of the Oncotype DX test is cost-effective in lymph node-negative patients for the United States, Canada and Japan by providing additional information to help doctors tailor treatment to the individual patient. The cost-effectiveness of Oncotype DX in lymph node-positive patients remains highly uncertain and assumes that the patient receives either high or low risk scores while censoring the intermediate group.

From the approximately 25,000 genes in the human genome, Genomic Health identified 250 candidate genes possibly associated with breast cancer tumor behavior in a 2002 literature review. These genes were analyzed in more than 400 patients from three independent clinical studies in order to identify a panel of 16 genes strongly correlated with distant recurrence-free survival. These 16 genes were added to 5 control genes for a total of 21 genes and were included in the assay (21-GA). OncotypeDX is the commercially available 21-GA.


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