70-Gene Breast Cancer Recurrence Assay

 

MammaPrint was the first breast cancer recurrence test for early-stage breast cancer cleared by the FDA that classifies your breast cancer as having either a Low Risk or High Risk of recurrence, which can help guide chemotherapy treatment decisions.

MammaPrint examines 70 of the most important genes that predict a cancer’s ability to spread or metastasize and is the only test of its kind that will give you a definitive result. There is no indeterminate or “intermediate” result. Definitive results from MammaPrint help you and your physician make the most informed, and confident decisions about your specific treatment plan.

Other non FDA-cleared genomic tests, such as the Oncotype DX test, only look at 21 genes and may give you an intermediate score, or an indeterminate result which provides no clarity on your chemotherapy treatment decision. Oncotype DX has shown to provide intermediate or indeterminate results between 39%1 and 67%2 of the time depending on the study. MammaPrint, in comparison, does not return indeterminate or intermediate results.

MammaPrint is the first and only test that has been validated in a randomized, prospective, phase III clinical trial. Recent results from the MINDACT clinical trial, provide the highest level of medical evidence (Level 1A), confirming MammaPrint’s ability to identify definitive Low Risk patients who may safely avoid chemotherapy.

In this study, 46% of patients identified as high risk for recurrence according to routine clinical-pathological assessment, and who therefore would be usual candidates for adjuvant chemotherapy, were reclassified as Low Risk by MammaPrint® and might not require chemotherapy.3

The diagnosis of breast cancer is life changing. Adding uncertainty with a test that provides indeterminate results only adds anxiety to this traumatic time.

MammaPrint Facts

What is the MammaPrint 70-Gene Breast Cancer Recurrence Assay?
MammaPrint is a 70-Gene genomic test for early-stage breast cancer patients that looks specifically at your breast cancer’s genes and will tell you if you have a Low Risk or a High Risk of cancer recurrence.

If you have a Low Risk of recurrence, you may be able to safely forego chemotherapy.

If you have a High Risk of recurrence, your cancer is most likely more aggressive and you may benefit from chemotherapy.

Please consult your physician to see if MammaPrint is right for you. Furthermore, all tests results should be carefully reviewed with your physician before any treatment decisions are made.

Why should my physician order MammaPrint instead of other breast cancer recurrence tests?
MammaPrint provides definitive results, only High or Low Risk results. There are no intermediate or indeterminate results, which leave you and your physician questioning whether or not Chemotherapy is needed. Click HERE for more information on MammaPrint’s definitive results.

Additionally, MammaPrint is the only breast cancer recurrence assay that is supported by Level 1A evidence, which is the highest level of evidence available. This data (from the MINDACT trial) was recently published in New England Journal of Medicine. Click HERE for more information on the MINDACT Study.

MammaPrint is the first and only genomic assay with FDA 510(k) clearance for use in risk assessment for women of all ages with early-stage breast cancer. FDA 510(k) clearance assures the safety of a product with thorough analytical validation by the U.S. Food and Drug Administration, that other Laboratory Developed Tests without such clearance (i.e. Oncotype DX) are not required to provide.

[1] Carlson, JJ., et al. Breast Cancer Res Treat. (Aug 2013) 141(1): 13–22

[2] Sparano, JA., et al. N Engl J Med. 2015 Nov 19;373(21):2005-14.

[3] Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.