MammaPrint and BluePrint Breast Cancer Testing

What the tests measure and how results support treatment discussions

Key takeaways

• MammaPrint studies the activity of 70 genes in breast tumor tissue and assigns a recurrence risk classification.
• BluePrint studies the activity of 80 genes and classifies the tumor as Luminal type, HER2 type, or Basal type.
• These are tumor gene expression tests. They are not inherited BRCA testing and do not show whether a cancer risk runs in the family.
• The two results are interpreted with stage, lymph nodes, grade, hormone receptors, HER2 testing, health, and treatment goals.
• A result supports a treatment discussion but does not make a treatment decision by itself.

What tumor gene expression testing means

MammaPrint estimates recurrence risk from a 70 gene expression profile. BluePrint classifies the tumor into a molecular subtype using an 80 gene expression profile. Together they add tumor biology to the clinical and pathology picture.

Every tumor contains genes, but those genes are not all equally active. Gene expression testing measures patterns of activity in RNA made by the tumor. The pattern can reveal behavior that is not visible from the microscope alone.^[2][3]

Expression testing and mutation testing

Expression testing asks which genes are switched up or down in the tumor. Mutation testing asks whether the DNA sequence contains a change. Germline testing asks whether a person was born with an inherited change. These questions are related but not interchangeable.

Test question	Material studied	Typical purpose
Gene expression	RNA activity in tumor tissue	Describe recurrence biology or molecular subtype
Tumor mutation	DNA or RNA changes in tumor tissue	Identify alterations that may inform therapy or trials
Germline	Usually blood or saliva	Assess inherited cancer susceptibility

What MammaPrint measures

MammaPrint measures a 70 gene expression signature in breast tumor tissue. Its main output is a genomic risk classification for distant recurrence. Depending on the current report format, the result may be presented along a scale with categories such as UltraLow, Low, High 1, and High 2. The report legend and the oncology team should be used to interpret the exact category.^[1][2][5]

Genomic risk is different from clinical risk. Clinical risk uses findings such as tumor size, grade, lymph node status, and age. When the two differ, the discrepancy is a reason for careful discussion, not a reason to ignore either source of information.

What a category does not mean

• Low risk does not mean recurrence is impossible.
• High risk does not mean recurrence is certain.
• The category alone does not provide every person's absolute benefit from chemotherapy.
• The test does not diagnose breast cancer or monitor whether treatment is working.

What BluePrint measures

BluePrint measures an 80 gene expression signature and identifies the dominant molecular biology as Luminal type, HER2 type, or Basal type. The highest of the three subtype scores determines the reported classification.^[1][3]

BluePrint can add biological context when the molecular subtype and routine pathology do not line up exactly. It complements rather than replaces estrogen receptor, progesterone receptor, and HER2 testing by IHC or in situ hybridization.

How the results work together

The combination brings together two questions. MammaPrint asks about the likelihood of distant recurrence. BluePrint asks which biological pathway most strongly characterizes the tumor. In a Luminal type tumor, the MammaPrint result may also support a Luminal A type or Luminal B type summary in the combined interpretation.

Result	Main question	How it can help	What it cannot do alone
MammaPrint	What is the genomic recurrence risk	Add tumor biology to chemotherapy discussions	Guarantee recurrence or treatment benefit
BluePrint	Which molecular subtype is dominant	Clarify Luminal HER2 type or Basal biology	Replace standard receptor pathology
Combined review	How do risk and subtype fit the clinical picture	Support an individualized discussion	Choose treatment without clinician review

The MINDACT study tested how MammaPrint genomic risk could add information when clinical and genomic risk were considered together. Its results support using the assay as one part of shared decision making in appropriately selected patients.^[6][7]

Who may be considered for testing

Testing may be considered when an oncologist needs additional information about the biology of an invasive breast cancer and that information could change a treatment discussion. Eligibility varies by country, stage, lymph node involvement, tumor size, prior treatment, and the validated use of the assay.

Agendia's current rest of world requisition materials describe MammaPrint testing for women with Stage I through Stage III breast cancer, with more specific criteria for some FFPE cases. BluePrint is listed for Stage I through Stage III disease. These forms are operational references, not a substitute for local oncology guidance.^[4]

Questions that shape eligibility

• Is the cancer invasive and has the diagnosis been confirmed by pathology
• Will the result answer a treatment question that remains uncertain
• Is adequate untreated or appropriately collected tumor tissue available
• Do current guidelines and local access support using the test in this setting

What sample is needed

Verified Oncquest offering facts

1

Combined breast-cancer offering

The official Oncquest information describes the combination as a recurrence risk and molecular subtyping test for breast cancer.

Why it matters for you

Agendia describes the two signatures as complementary views of tumor biology.

2

Listed turnaround

The Oncquest FAQ lists a turnaround of about 18 working days for the combination after an adequate specimen is available.

Why it matters for you

Timelines can change because of tissue review, transport, holidays, or repeat processing, so confirm the current estimate when ordering.

The tests generally use formalin fixed paraffin embedded tumor tissue from a core biopsy or surgery. Because existing diagnostic tissue can often be used, a separate procedure is not usually needed solely for the assay. A pathologist selects a tumor rich area and confirms that the material is suitable.^[2][4][5]

1. Select the tissue
   The laboratory or pathology team identifies the most appropriate block or slides.
2. Confirm adequacy
   Tumor amount and tissue quality are checked before testing begins.
3. Send clinical details
   The requisition should include diagnosis stage pathology and treatment context.
4. Track the specimen
   Turnaround starts after the testing laboratory receives an adequate sample.

How to read the report

1. Check identity
   Confirm patient details specimen site diagnosis and collection information.
2. Review sample quality
   Look for tissue adequacy or quality comments that may limit interpretation.
3. Find the MammaPrint result
   Read the risk category and its position on the report scale.
4. Find the BluePrint result
   Read the molecular subtype and the subtype score pattern.
5. Compare with pathology
   Review ER PR HER2 grade nodes and stage alongside the molecular result.
6. Discuss the decision
   Ask what the result changes and what it does not change in the treatment plan.

If a headline label appears to conflict with the score, legend, or nearby explanation, do not try to resolve the conflict by inference. Ask the laboratory to clarify or amend the report before it is used for a treatment decision.

How results support treatment discussions

The report becomes clinically useful only when it is placed beside the rest of the record. A multidisciplinary team may consider the genomic information together with the following factors.

Factor	Why it matters
Stage and lymph nodes	Describe how far the cancer has spread and influence baseline risk
Tumor size and grade	Describe tumor burden and microscopic aggressiveness
ER PR and HER2	Guide established endocrine and HER2 directed treatment pathways
Age and menopause	Can affect baseline risk evidence and treatment tradeoffs
Health and preferences	Shape the balance of potential benefit burden and toxicity
Current guidelines	Define when genomic assays and treatments are supported

What the tests cannot tell you

• They cannot promise whether cancer will or will not recur.
• They cannot determine the best treatment without clinical and pathology review.
• They do not replace ER PR HER2 staging imaging or other tests needed for care.
• They do not identify inherited cancer risk. Germline testing is a separate test.
• They do not assess every possible feature of a tumor or how it may change over time.
• They may not produce a result if the tissue is insufficient or RNA quality is poor.

Why context can change interpretation

Clinical evidence, guidelines, and report formats evolve. A result should be interpreted using the evidence available when the treatment decision is made. If the report is old or the disease has changed, the oncology team may revisit whether the original result still answers the current question.

Useful questions for the appointment

• Why is this test being considered in my case
• What decision could change because of the result
• How does the result compare with my pathology and clinical risk
• Would any other test still be needed
• What are the possible benefits uncertainties and harms of each treatment option

Frequently asked questions

FAQs

Are MammaPrint and BluePrint the same test

No. They are commonly ordered together, but MammaPrint reports genomic recurrence risk and BluePrint reports molecular subtype.^[2][3]

Is this an inherited cancer test

No. These tests measure gene expression in tumor tissue. A family history concern is evaluated with genetic counselling and a separate germline test.

Does a Low risk result mean chemotherapy is never needed

No. The result is one factor. Stage, nodes, receptors, age, health, guideline recommendations, and preferences still matter.^[6][7]

Can BluePrint replace HER2 testing

No. BluePrint adds molecular subtype information but does not replace validated ER PR HER2 pathology tests.^[3]

Will I need another biopsy

Often the laboratory can use an existing core biopsy or surgical FFPE specimen. The pathology and oncology teams must confirm that the tissue is adequate.^[2][4]

How long will the result take

Oncquest currently describes about 18 working days after an adequate specimen is available. Confirm the current estimate because transport tissue review or repeat processing can affect timing.^[1]

What should happen if wording in the report conflicts

Pause clinical use of the unclear statement and ask the issuing laboratory for clarification or a corrected report. Do not choose between conflicting labels by guesswork.

Sources

1. Oncquest Field Assist MammaPrint and BluePrint FAQ Local overview of intended use specimen information outputs and listed turnaround
2. Agendia MammaPrint Official overview of the 70 gene expression assay and recurrence risk output
3. Agendia BluePrint Official overview of the 80 gene molecular subtyping assay
4. Agendia Rest of World Test Requisition Form Current ordering indications and specimen guidance for markets outside the Americas
5. Agendia MammaPrint FFPE Physician Brochure Technical and clinical overview for FFPE tumor testing
6. MINDACT Primary Analysis Prospective randomized evidence on clinical and genomic risk
7. MINDACT Updated Analysis Long term follow up and age exploratory analysis
8. Agendia Patient Brochure Patient oriented explanation of the combined assays