Genomic Profiling of Breast Cancer Two tests. A more complete view of tumor biology.
MammaPrint + BluePrint is a combination of genomic tests for breast cancer that analyzes gene activity in tumor tissue.
MammaPrint evaluates the genomic risk of recurrence/distant metastasis, while BluePrint determines the molecular subtype of the tumor.
Together, these results can provide the oncologist with additional information about tumor biology and help with more personalized treatment planning, alongside clinical and pathological factors.
What is MammaPrint?
MammaPrint is a genomic test that analyzes the expression of 70 genes associated with breast cancer biology.
It classifies the tumor as:
The purpose of MammaPrint is to assess the risk of developing distant metastases, particularly within 5 years of diagnosis, and to provide prognostic information that is used together with clinical and pathological characteristics.
What is BluePrint?
BluePrint is a genomic test that analyzes 80 genes to determine the molecular subtype of breast cancer.
It classifies the tumor into one of three molecular subtypes:
Luminal-Type
Tumors characterized primarily by the activity of hormone-related pathways.
When combined with the MammaPrint® result, Luminal-Type tumors may be further classified as Luminal A-Type or Luminal B-Type.
HER2-Type
Tumors in which HER2 pathway activity is dominant at the molecular level.
Basal-Type
Tumors with more aggressive biology and molecular characteristics similar to basal-like tumors.
BluePrint® can identify differences between the molecular subtype and traditional pathological classification, providing a more detailed view of tumor biology.
Why are MammaPrint and BluePrint combined?
Traditional pathological analysis provides important information about tumor characteristics, but genomic profiling can provide additional information about tumor biology and gene activity.
The combination:
MammaPrint → How high is the genomic risk?
BluePrint → What molecular subtype does the tumor have?
This can provide the physician with a more complete picture when discussing the therapeutic strategy. What information does MammaPrint® provide?
MammaPrint® provides a genomic risk classification:
Low Risk The tumor is classified as having a low genomic risk of distant metastasis.
High Risk The tumor is classified as having a high genomic risk.
The result is prognostic information and should not be interpreted separately from other clinical and pathological factors.
What additional information does BluePrint® provide?
BluePrint® can help identify the molecular biology of the tumor:
Luminal-Type → biology primarily associated with hormone-related pathways
HER2-Type → biology driven by the HER2 pathway
Basal-Type → basal/proliferative biology
This may be particularly important when the molecular subtype does not fully correspond to the traditional classification based on IHC/FISH.
Who is it recommended for?
MammaPrint + BluePrint is intended for the evaluation of patients with early-stage breast cancer, according to defined clinical and pathological criteria.
According to the test’s intended-use information, the analysis may be used in patients with:
stage I or II disease; negative lymph nodes; or up to 3 positive lymph nodes; tumors up to 5 cm;
and its use may also extend to certain stage III situations, depending on the indication and clinical assessment.
Test suitability is determined by the oncologist, taking into account the diagnosis and the patient’s characteristics. What type of material is used for the test?
MammaPrint + BluePrint is performed using tumor tissue, usually material preserved after a biopsy or surgical procedure.
The test can be performed on FFPE (formalin-fixed, paraffin-embedded) tumor tissue.
It is not a test performed solely using a blood sample.
How is the analysis performed?
1. Tumor material is obtained
Available material from the biopsy or surgery is used. 2. Gene expression is analyzed
The laboratory analyzes the expression of the genes included in the MammaPrint® and BluePrint® signatures. 3. The genomic profile is generated
MammaPrint determines the risk category, while BluePrint® determines the molecular subtype. 4. The result is interpreted by the oncologist
The results are combined with clinical and pathological data to help guide treatment planning.
The current version of the test uses Next Generation Sequencing (NGS) technology to analyze gene expression.
Does MammaPrint replace biopsy or histopathology?
No.
MammaPrint® and BluePrint® do not replace histopathological diagnosis, immunohistochemistry, or clinical assessment.
They provide additional genomic information about the tumor.
The results should be interpreted together with:
Does the test help with the decision about chemotherapy?
MammaPrint® can help assess genomic risk, which may be an important component when discussing the potential benefit of systemic treatments.
However, the result should not be interpreted as an automatic “chemotherapy yes/no” decision.
The therapeutic decision is made by the oncologist by integrating the genomic result with all of the patient’s clinical and pathological factors.
Can the tumor subtype change?
Yes.
BluePrint® can identify a molecular subtype that differs from the classification based solely on IHC/FISH.
Agendia reports that BluePrint® has reclassified a proportion of tumors into a different molecular subtype, demonstrating that the functional biology of a tumor may not always correspond to traditional classification. MammaPrint® + BluePrint® and personalized treatment
The purpose of genomic profiling is to help the physician better understand the individual biology of the tumor.
The combined information may contribute to discussions regarding:
This information does not replace the oncologist’s clinical judgment. MammaPrint + BluePrint vs. traditional tests
MammaPrint® is a 70-gene test that evaluates the genomic risk of distant metastasis in breast cancer.
BluePrint® is an 80-gene test that determines the molecular subtype of the tumor: Luminal, HER2-Type, or Basal-Type.
Because MammaPrint provides information about genomic risk, while BluePrint® provides information about the tumor’s biology/molecular subtype.
MammaPrint® analyzes 70 genes and BluePrint® analyzes 80 genes. These are two different gene signatures and should not simply be added together as “150 unique genes,” because there is overlap and interpretation is based on the respective signatures.
No. The analysis is performed using tumor tissue, usually FFPE tissue.
Yes, provided that suitable tumor material is available for analysis and the patient meets the clinical criteria.
MammaPrint and BluePrint are tests developed for breast cancer.
No. Cancer diagnosis is made through clinical assessment, imaging, and particularly histopathological examination. MammaPrint + BluePrint is used when tumor material is available to further characterize the disease.
The result may help assess risk and the potential benefit of treatment, but the decision regarding chemotherapy is made by the oncologist.
BluePrint® identifies the Luminal-Type subtype, while combining the Luminal result with the MammaPrint category can be used for Luminal A/B stratification according to the relevant algorithm.
Yes. BluePrint can reclassify some tumors into a different molecular subtype compared with traditional pathological classification.
No. The result should be interpreted by the oncologist together with all clinical and pathological data.
Yes. MammaPrint is used as a prognostic marker to assess the risk of distant metastasis, together with other clinical and pathological factors.
