Oncotype DX for Breast Cancer has a
10+ Year Track Record with Over
750,000 Patients Tested Worldwide


For Early-Stage Invasive Breast Cancer, Stage I-IIIa Oncotype DX MammaPrint Prosigna1
Outcomes evidence in more than 63,000 patients worldwide confirming accurate prediction of breast cancer recurrence and survival ✓︎ NO NO
Predicts response to chemotherapy ✓︎ NO NO
Predicts risk of recurrence ✓︎ ✓︎ ✓︎
Recognized worldwide as the standard of care  ✓︎ NO NO
Widely Reimbursed
in the U.S.
✓︎ NO
Medicare & select private insurance
✓︎

 

For DCIS, Stage 0 Breast Cancer2 Oncotype DX MammaPrint Prosigna
Predicts risk of local recurrence ✓︎

 
NO
No Test Available
NO
No Test Available

 

It is essential that all newly diagnosed breast cancer patients, and the people who love them, understand the important distinctions between these tests so that they can get the information they need to make a well-informed, personalized treatment decision.

To date, the Oncotype DX breast cancer test for early-stage invasive breast cancer patients is the only test validated to predict who benefits from chemotherapy as well as the risk of distant recurrence, and the only test included for treatment decision-making in the leading breast cancer treatment guidelines worldwide. As a result, it has been broadly adopted by the physician community and has changed the treatment paradigm for patients with estrogen receptor positive disease. The Oncotype DX breast cancer test is widely reimbursed in the United States, and has been used to guide treatment in over 750,000 breast cancer patients internationally and is recognized as the standard of care for women with early-stage breast cancer.

Evidence in more than 63,000 patients shows that Oncotype DX accurately predicts outcomes for early stage patients with invasive breast cancer. Patients with a Recurrence Score less than 18 and treated with hormonal therapy alone have excellent breast cancer survival at five years. The unprecedented amount of data is based on four large, independently run, international studies reconfirming that Oncotype DX accurately predicts clinical outcomes – including risk of recurrence and breast cancer survival. Data include results from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI); complete results from a multi-center study from Clalit Health Services, the largest healthcare services provider in Israel; and additional analysis from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by the ECOG-ACRIN Cancer Research Group. While the TAILORx study reported initial results from the group of patients with a Recurrence Score <11, the Clalit registry included patients with the full range of scores in the low group (0-17), the intermediate group (18 to 30) and the high group (>31). The use of chemotherapy in the risk groups was 2%, 28% and 86%, respectively. Of note, the intermediate risk group had only slightly higher rates of distant recurrence and breast cancer specific mortality at five years compared to the low risk group.

The Oncotype DX breast cancer test for DCIS is the first and only clinically validated genomic test for DCIS to provide an individualized prediction of the 10-year risk of local recurrence (DCIS or invasive carcinoma), which can help guide treatment decisions in women treated by surgery alone. The lower the DCIS Score result, the lower the chances that the cancer will come back in the same breast; the higher the score, the greater the chances that the cancer will come back in the same breast (local recurrence).

The Oncotype DX test analyzes multiple genes within a patient’s tumor sample to calculate an individualized score between 0 and 100 that is unique to each woman, reflecting the continuous breast cancer biology.

If it's whether or not to use chemotherapy in addition to hormonal therapy for estrogen receptor positive breast cancer or to determine the risk of local recurrence for DCIS – the answer is clear. Oncotype DX is the only test that has been developed and validated for those purposes.

1 MammaPrint is a registered trademark of Agendia BV. Prosigna is a trademark of NanoString Technologies, Inc. Please refer to these manufacturers directly for more information.
2 The Oncotype DX breast cancer test for early-stage invasive breast cancer has been available since 2004. The Oncotype DX breast cancer test for DCIS has been available since 2011. To date, the majority of tests provided have been for patients with early-stage invasive breast cancer.
3 These organizations do not endorse any product or therapy.

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