Clinician FAQs

Answers to Important Questions You May Have

The MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit is indicated for use in breast cancer patients with Stage I and II invasive breast cancer, with a tumor size of ≤ 5.0 cm, independent of estrogen receptor status (ER+/-) who are lymph-node negative or with up to three positive lymph-nodes. The test has been validated for use in female breast cancer patients of all ages and ethnicities. The MammaPrint test is intended for in vitro diagnostic use as a prognostic marker only along with other clinic-pathological factors. The test is not intended for diagnosis, or to predict or detect response to therapy or to select the optimal therapy for patients.

The turnaround time for each sample depends on the reference laboratory. Please contact your partner reference laboratory directly to better understand when you should expect results after your patient’s sample has been submitted. MammaPrint and BluePrint tests are also available through Agendia Lab Services using microarray technology.

If you are ordering the test directly though Agendia Lab Services, please contact Agendia Customer Service at [email protected] or by telephone at +31 (0) 20 462 1510, Monday through Friday from 08:30 to 17:00 (GMT/UTC +1).

The MammaPrint and BluePrint tests should be ordered as soon as possible after your patient has been diagnosed with breast cancer, as the results can help to guide treatment management decisions.

If your laboratory is interested in becoming an Agendia Partner Reference Lab, or if you are interested in ordering a MammaPrint or BluePrint test for a patient, please contact Agendia Customer Service at [email protected] or by telephone at +31 (0) 20 462 1510, Monday through Friday from 08:30 to 17:00 (GMT/UTC +1).

Based on data from the peer-reviewed published MINDACT Trial, if your patient receives a MammaPrint Low Risk result, they have a very low risk of distant metastasis within 5 years and are therefore unlikely to show a significant benefit from chemotherapy. A Low Risk patient has an average 2.2% risk of distant recurrence at 5 years, on hormonal therapy alone (average risk of recurrence for ER-positive / HER2-negative / LN-negative patients).1

A MammaPrint Low Risk result does not guarantee that a patient’s cancer will not recur. These results, in addition to all other clinical factors, can help personalizing breast cancer treatment decisions.

Visit the MammaPrint page of this website for more information.

Based on the peer-reviewed published MINDACT Trial, if your patient receives a MammaPrint High Risk, there is an average of 5.4% risk of distant metastasis at five years if they are treated with chemotherapy in addition to hormonal therapy (average risk of recurrence for ER-positive / HER2-negative / LN-negative patients)1.

MammaPrint High Risk patients can be further divided into subtypes based on the genomic profile of the tumor, which may help to refine the treatment management plan. These subtypes provide additional information about how a patient’s tumor may best respond to: hormone therapy, chemotherapy, targeted therapy, or a combination.

A MammaPrint High Risk result doesn’t guarantee that a patient’s cancer will not recur.

These results, in addition to all other clinical factors, can help personalizing breast cancer treatment decisions.

Visit the MammaPrint page of this website for more information.

BluePrint is an 80-gene molecular subtyping test that determines a tumor’s functional molecular subtype. 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 driving the tumor’s proliferation.

Combined with MammaPrint, BluePrint will determine if your patient’s breast cancer is Luminal-type (A or B), Basal-type, or HER2-type. These findings are important when deciding which treatment may be most appropriate, based on the specific molecular subtype of the tumor.

Visit the BluePrint page of this website for more information.

MammaPrint and BluePrint provide a deeper insight into tumor pathways by uncovering the tumor biology. By combining risk of recurrence with molecular subtyping, you get a clearer picture of how a patient’s breast cancer is functioning, leading to a better-informed treatment assessment.

MINDACT was a prospective, randomized, phase III, controlled clinical trial that investigated the clinical utility of MammaPrint, when used in conjunction with standard clinical pathological criteria, for the selection of patients unlikely to benefit from adjuvant chemotherapy. From 2007 to 2011, 6,693 women who had undergone surgery for early-stage breast cancer were enrolled in the trial, across 112 centers in nine countries.

The study showed that 46% of patients identified as high risk for recurrence according to clinical-pathological factors as described in the publication, and who therefore would be usual candidates for adjuvant chemotherapy, were reclassified as Low Risk by MammaPrint and MINDACT shows could potentially avoid unnecessary chemotherapy.1

Visit the MammaPrint page of this website for more information on the MINDACT Trial.

If a patient with Stage I or II breast cancer is considered high risk by clinical-pathological factors, there is still value in ordering the MammaPrint test to complement the clinical-pathological assessment. If the MammaPrint result is Low Risk, there may not be significant benefit of chemotherapy.

Yes, you can always order a MammaPrint test for your patient. When other prognostic test results come back with intermediate or ambiguous results, the MammaPrint test’s binary High or Low Risk results can help to provide clarification. Please be sure the patient clarifies their specific insurance coverage so they are aware of any potential out-of-pocket costs.

MammaPrint is recognized or recommended by major international and national medical societies’ clinical guidelines including, the St. Gallen International Breast Cancer Consensus, the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO) the German Gynecological Oncology Group (AGO) and the European Group on Tumor Markers (EGTM).

Visit the Resource page of this website for sample Explanation of Results pages.

Test reimbursement varies from country-to-country and by the patient’s individual insurance plan. Please have your patient reach out to their insurance provider to discuss their coverage.

Resources

  1. Cardoso F. N Engl J Med 2016; 375: 715-729