MammaPrint Test

The best way to guide therapeutic options towards personalized treatment
The best way to understand each woman's breast cancer

The MammaPrint® test analyzes the 70 most relevant genes associated with breast cancer recurrence. In addition, you benefit from molecular pathology included with the BluePrint® test. The results are available in a maximum of 10 working days. MammaPrint enables faster and more informed decisions about pre- and post-operative treatment and can be easily integrated into diagnostic analyses.¹

DEFINITIVE RESULTS FOR ADJUVANT CHEMOTHERAPY PLANNING

LOW RISK PATIENTS HAVE A
1.3%
CHANCE OF RECCURENCE²

The MINDACT trial determined these patients do not benefit from chemotherapy.³

46%

HIGH RISK PATIENTS HAVE A
11.7 %
CHANCE OF RECCURENCE²²

These patients were shown to have significantly better outcomes with chemotherapy.⁴
Nearly half of clinically high risk patients were reclassified as MammaPrint Low Risk and were able to forgo chemotherapy without compromising their outcomes.³

Interrogating 80 genes, the BluePrint^® test identifies the underlying biology of an individual breast cancer. The tumor is then accurately classified as one of three subtypes, which reveal valuable information about its behavior, long-term prognosis and response to systemic therapy. Results are typically available in <6 days, just in time for your pre-operative consultation.^6,7

Luminal Type

Luminal-Type cancers are primarily driven by the estrogen and progesterone hormone pathways. This subtype can be further stratified using MammaPrint into Luminal A-Type cancers (Low Risk) and Luminal B-Type cancers (High Risk). These luminal subtypes have distinctly different outcomes and thus this information should be incorporated into treatment planning to maximize the likelihood of curing your patient.

HER2 Type

HER2-Type cancers are primarily driven by the HER2 pathway. This molecular subtype does not always align with IHC- or FISH-derived HER2 results but HER2-Type patients have excellent response to HER2-targeted therapies in the neoadjuvant setting. In fact, with advances in therapeutics, HER2-Type patients have good long term outcomes when treated with HER2-targeted agents.

Basal Type

Basal-Type tumors are not driven by ER, PR or HER2 pathways and act more like clinically triple negative tumors. This molecular subtype is more aggressive and patients may benefit from standard or novel regimens for triple-negative breast cancers. Given the aggressive nature of these tumors, appropriate patients may benefit from neoadjuvant rather than adjuvant treatment.

Women who benefit:

Newly diagnosed with invasive breast cancer (stage I, or II or operable stage III)
Lymph node-negative or those with 1-3 positive lymph nodes
Tumor size up to 5 cm
All ages

RECLASSIFICATION

ER+/BASAL PATIENTS ARE

BluePrint BASAL-TYPE

MAMMAPRINT HIGH RISK

Clinically, these patients appear to have less aggressive tumors but the underlying biology indicates they will act like triple negative breast cancer.⁷Treating ER+/Basal patients more aggressively may improve their outcomes.

22%

ER+, HER2+/LUMINAL PATIENTS ARE

BluePrint LUMINAL-TYPE

MAMMAPRINT HIGH RISK

Nearly 50% of pathologically HER2+ patients are reclassified to a Luminal molecular subtype. ER+, HER2+/Luminal patients do not respond as well to treatment with HER2- targeted agents as those who have concordant clinical and molecular HER2 subtypes.⁸

In NBRST study, 22% of patients were reclassified from their original clinical or pathological subtype into a different molecular subtype identifying an opportunity to personalize treatment to the patient’s molecular profile.⁹

Only the genomic information rendered by MammaPrint® + BluePrint® can confidently guide breast cancer treatment planning over the next 10 years.

Confidently and rapidly establish a personalized treatment plan for your patients*, from neoadjuvant chemotherapy decisions to endocrine therapy extension, using MammaPrint + BluePrint results, which are available in up to 10 business days¹.

* Women with a minimum age of 18 years, with a diagnosis of breast cancer, in its early form

Functional genomic profiling with MammaPrint + BluePrint

With the combined results of MammaPrint + BluePrint, along with clinical factors, physicians obtain a more comprehensive basis for making informed decisions regarding pre- and post-operative treatment and can assess the benefit of certain treatments.

Find the probability of cancer recurrence of breast.

Determine the genomics underlying influencing tumor growth.

HIGH GENOMIC RISK

Your cancer is much more likely to come back in the next 10 years.

You are much more likely to benefit from chemotherapy.

LOW GENOMIC RISK

Your cancer is less likely to come back after 10 years.

You are unlikely to benefit from chemotherapy.

^References:
^{1. McKelley, et al. SABCS 2020.

2. Whitworth, et al (2022) Distinct Neoadjuvant Chemotherapy Response and 5-year outcome in patients with ER+, HER2- Breast Tumors That Reclassify as Basal-type by the 80-gene signature.

Blu ePrint basal subtype predicts neoadjuvant therapy response in ~400 HR+HER2- patients across 8 arms in the I-SPY 2 TRIAL. Presentation, EORTC-NCI-AACR. Dublin, Ireland. November 2018.

Whitworth, et al. SABCS 2020, Poster #PD9-01.

Whitworth, P., et al. Ann Surg Oncol. 2017;24(3):669-675.

Groenendijk, F, et al. NPJ Breast Cancer. 2019;5:15.

3. Lopes Cardozo at al (ASCO 2020), Piccart et al (Lancet Oncol 2021), Lopes Cardozo, J., et al JCO 2022.

70 -gene signature as an aid for treatment decisions in early breast cancer: Updated results of the phase three randomized MINDACT trial with an exploratory analysis by age. Prof Martine Piccart, MD et al. The Lancet

Oncology 22, no. 4. March 12, 2021. 476-488. https://doi.org/10.1016/S1470-2045(21)00007-3

4. Use of Molecular Tools to Identify Patients with Indolent Breast Cancers with Ultralow Risk Over 2 Decades. Laura J. Esserman, MD, MBA et al. JAMA Oncology 3, no. 11. June 29, 2017. 1503–1510.

https://doi.org/10.1001/jamaoncol.2017.1261

5. Utility of the 70-gene MammaPrint assay for prediction of benefit from extended letrozole therapy (ELT) in the NRG Oncology/NSABP B-42 trial. Priya Rastogi et al. Abstract,

Journal of Clinical Oncology 39 no. 15. May 20, 2021. 502-502.

6. BluePrint is a laboratory-developed test that was developed, validated and is performed exclusively by Agendia. The test is intended for clinical purposes. The test has not been cleared by the U.S. Food and Drug Administration (FDA) but has been CE-marked for use in Europe. The laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of the tests. Our laboratories are CAP-accredited and certified under CLIA to perform high complexity clinical laboratory testing. (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)

7. Groenendijk FH, et al. NPJ Breast Cancer. 2019;5:15.

8. Rong P et. al. Cancer Res 2018;78(13 Suppl):Abstract nr 2612.

9. Whitworth, et al. Ann Surg Oncol (2017) 24:669–675}