MammaPrint® 70-Gene Breast Cancer Recurrence Test
MammaPrint is currently the only breast cancer recurrence test backed by peer-reviewed, prospective outcome data. Unlike other genomic tests, your doctor is provided with a MammaPrint Low Risk or High Risk result, eliminating the uncertainty of an intermediate risk score which can affect up to 39% of patients tested.3 A MammaPrint Low Risk result means you have a 10%, or 1 in 10 chance of your cancer returning. A MammaPrint High Risk result means you have a 29%, or 3 out of 10 chance of it returning.9 These results are based on a 10-year follow-up of a reference group of patients who had no additional treatment. These results, in addition to all other factors help you and your doctor make the most appropriate breast cancer treatment decisions.
BluePrint® 80-Gene Molecular Subtyping Assay
BluePrint molecular subtyping provides deeper insight into tumor pathways, uncovering your hidden tumor biology. Molecular subtyping informs your doctor about how the tumor is functioning underneath the surface. Traditional subtyping (such as IHC or FISH) assess a tumor by looking at cell surface characteristics, while molecular subtyping looks deeper at the functional level, to see which genes are really driving the tumor’s behavior. BluePrint will determine if your breast cancer is Luminal-type (A or B), Basal-type, or HER2-type. These findings are important when determining the treatments that are most appropriate for your specific tumor.
Low Risk or High Risk result: No Intermediate category
Having easy-to-interpret information helps you and your doctor make the most appropriate treatment management decisions. MammaPrint’s binary results removes the ambiguity you may get with other genomic tests, which have been shown to be as high as 39% of patients tested.3
Strong Prognostic Power, proven long-term
A 25-year follow-up study to the original New England Journal of Medicine publication of MammaPrint showed that these results have durable, accurate, long-term prognostic value. These results are the longest-term follow-up study of its kind.
“This remarkable long-term study demonstrates the ability of the 70-gene signature to accurately differentiate higher-risk from lower-risk women with regard to risk of recurrence and overall survival, at a time in their lives when breast cancer can have its most devastating impact on fertility, productivity, and capacity to fulfill child-rearing responsibilities,”
MammaPrint and BluePrint are intended for prognostic use only. MammaPrint result is not intended to determine the outcome of disease, not to suggest or infer an individual’s response to therapy. A MammaPrint Low Risk result does not ensure that distant risk of recurrence will not recur. Similarly, a High Risk result does not ensure that distant risk of recurrence will occur. Test results should be used in conjunction with other clinic-pathological factors and standard practice of medicine.
In the U.S., MammaPrint is an FDA cleared test, performed in a central laboratory using gene expression profiles obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples, to assess a patient’s risk for distant metastasis within 5 years. BluePrint is a laboratory-developed test that was developed and is performed exclusively by Agendia.
In the EU, MammaPrint and BluePrint are CE marked tests, performed in a central laboratory, using gene expression profiles obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples.
What To Ask Your Doctor
Ask your doctor to run the Agendia Breast Cancer Test Suite on your breast cancer. These tests can be run on a sample of your tumor that was removed during biopsy or surgery and was embedded in paraffin for storage (FFPE tissue). No new biopsy or surgical tissue sample is usually required.
If your doctor is unfamiliar with Agendia testing, please call Customer Care at 888-321-2732, and we can help connect them with a local Agendia Oncology Specialist.
Cleared by the FDA
With FDA clearance, have confidence in your results8
MammaPrint received FDA clearance in 2007 and was the first in vitro diagnostic multivariate index assay (IVDMIA) to be cleared by the regulatory agency. An IVDMIA is a device that combines the values of multiple variables using an interpretative function (bioinformatics algorithm) to provide a single, patient specific result, that is intended for use in the diagnosis of disease and which provides a result whose derivation is non-transparent, and for that reason, cannot be independently derived or verified by the end user.
MammaPrint’s FDA clearance confers confidence in its safety and effectiveness, ensuring that the peer reviewed, published studies used in its development, validation and IVDMIA clearance have been evaluated by the United States Food and Drug Administration. The FDA label indicates that as a diagnostic tool, MammaPrint has a 98.9% degree of accuracy in classifying patients as Low Risk or High Risk and technical reproducibility of 98.5%.
MammaPrint’s FDA indication – patient eligibility in the USA
Breast cancer recurrence and/or metastasis is partly dependent on the activation and suppression of certain genes located within the primary breast tumor. The FDA cleared MammaPrint profile is a FFPE tissue based genomics test which uses the latest microarray technology to analyze a patient’s breast tumor biology to predict whether existing cancer has the ability to metastasize. This 70-gene profile is validated as an independent indicator for breast cancer prognosis for women with lymph node-negative, estrogen receptor positive breast cancer and estrogen receptor negative disease.
Ask your doctor if the MammaPrint test is right for you.
Participate in a clinical registry
Current Clinical Registry Trials
Agendia’s extensive clinical studies and research collaborations have produced numerous retrospective and prospective validation publications over the past decade. Recently published studies further support the prognostic and predictive clinical utility of MammaPrint for early stage breast cancer patients, and large, multi-institutional clinical trials, such as MINDACT and ISPY-2, can be expected to expand the assay’s clinical importance and indications for use. In the first ever phase III, prospective, randomized study for a breast cancer recurrence assay, the five year results of the Microarray In Node-negative (or 1-3 positive lymph node) Disease may Avoid ChemoTherapy (MINDACT) clinical trial showed 46% of clinically high risk patients were genomically Low Risk and showed no statistical benefit to chemotherapy.
Currently, Agendia is enrolling institutions and cancer centers worldwide in the following studies for Breast Cancer:
- MINT: The Multi Institutional Neo Adjuvant Therapy MammaPrint Project trial (NCT01501487)
Contact a customer care representative to learn more about participating in a clinical study. They can be reached at 888-321-2732 or by email at email@example.com