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Oncotype DX, developed by Genomic Health, is a diagnostic test that quantifies the likelihood of
disease recurrence in women with early-stage hormone estrogen receptor (ER) positive only
(prognostic significance) and assesses the likely benefit from certain types of
(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. Oncotype DX 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 aor aromatase inhibitors, is planned, and
the test can help define whether chemotherapy should or should not be added to that anti-
hormone treatment. Oncotype DX remains unproven for use in patients with carcinoma in situ
(precancerous)breast cancer. However, in an analysis of tissue samples
from a large clinical trial (SWOG 8814), Oncotype DX demonstrated both prognostic
significance (the capability of predicting distant recurrence) and predictive significance ( a
second and different characteristic that describes the capability of the test to assess the potential
benefit of additional adjuvant chemotherapy) in women with estrogen receptor positive early
breast cancer whose lymph nodes show spread of their tumor (node-positive), and the test has
also shown similar prognostic and predictive significance in women both either node negative or
node positive early breast cancer who received adjuvant treatment with the aromatase inhibitor
anastrozole. Moreover, small studies with tumor specimens from breast cancer patients receiving
neoadjuvant treatment show similar results and suggest that the test may predict response to
neoadjuvant hormonal therapy and chemotherapy.
Oncotype DX is a noninvasive test that is performed on a small amount of the tissue removed during the original surgeryoreh means no additional invasive procedure is required. After the surgical procedure, the tissue sample is fixed in formalin and embedded in paraffin so it can be preserved for further diagnostic testing. To perform Oncotype DX, the pathologist will send several thin sections of the formalin-fixed, paraffin-embedded tissue sample to Genomic Health. Oncotype DX uses a highly reproducible laboratory process known ato determineof the 21-gene panel. The Oncotype DX test results are then integrated with other laboratory test results to help doctors formulate a treatment plan based on the unique characteristics of the tumor. Since Oncotype DX became available in 2004, it has been used by over 10,000 physicians to help guide treatment for over 200,000 patients in 60+ countries.


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