MammaPrint – Breast Cancer Testing

MammaPrint is a gene expression profiling test (also referred to as a ‘genomic test’, ‘genomic assay’, or ‘gene expression profiling test’) that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. This FDA-cleared and CE-marked gene expression profiling test assesses a woman’s risk of distant metastasis and based on clinical evidence, provides critical answers that inform the future of woman’s treatment plans at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint listens to the signals from 70 key genes in a woman’s tumor and based on clinical evidence, stratifies recurrence risk within four distinct categories – ranging from UltraLow Risk, Low Risk, High Risk 1, and High Risk 2– to fuel a right-sized care plan tailored to each woman’s tumor biology and her life’s plans.

MammaPrint is performed on tumor tissue obtained by a healthcare professional from core needle biopsy or surgical resection. The tumor slides or FFPE (formalin fixed, paraffin embedded) tumor sample block is sent to the Agendia laboratory in Irvine, California where genomic analysis is conducted, and results are returned to the ordering physician to review with the patient. MammaPrint results are reported as a number (the MammaPrint Index) within four risk categories, each with their own clinical decision implications: UltraLow Risk, Low Risk, High Risk 1, and High Risk 2.

Once the tumor sample is received at the Agendia laboratory, results are typically made available to physicians within 6 days. ^†

† McKelley, et al. SABCS 2020. Agendia is committed to delivering results in less than 10 business days, and results are provided within 6 business days for the majority of cases.

The cost of MammaPrint can vary globally based on geographic location, insurance coverage, and individual circumstances. Contact your local healthcare provider with questions.

US and Puerto Rico: MammaPrint is reimbursed by CMS (Medicare) and most commercial health plans. If you have no health insurance or your health plan doesn’t cover the Agendia tests, you may be eligible for one of our four financial support programs – visit our Financial Support webpage for more information.

For patients: MammaPrint results should be interpreted by a healthcare provider who can explain what the risk classification means in the context of your overall diagnosis, medical history, and treatment options.

For physicians: if you want to discuss the clinical evidence and/or results please contact Agendia and we will put you in contact with your local Agendia representative.

No. MammaPrint does not require any additional procedures beyond the biopsy or surgical resection already performed by the surgeon to collect the tumor sample.

Clinical evidence demonstrates MammaPrint and our genomic tumor sub-typing test, BluePrint, can help answer many clinical treatment questions in early-stage invasive breast cancer. Results may help inform whether chemotherapy is likely to provide benefit and who may be able to avoid chemotherapy. Treatment decisions should be made collaboratively between a patient and their physician. Results should be taken in the context of other relevant clinico-pathological factors and standard practice of medicine.