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). There is emerging evidence that such tests may also provide information about the likely benefit from chemotherapy (predictive significance).
Oncotype DX analyzes 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 a specific likelihood of breast cancer recurrence within 10 years of the initial diagnosis, though the score is not validated, though the buckets of Low, Intermediate or High Risk are when the patient receives / abides to 5 years of Tamoxifen. 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.
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