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WHAT IS MINDACT?

  • The Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) study is a prospective, randomized, phase III, controlled clinical trial that investigates the clinical utility of MammaPrint®, when compared to (or used in conjunction with) standard clinical pathological criteria, for the identification of patients unlikely to benefit from adjuvant chemotherapy. Some of highlights for this landmark trial include:
    • 6,693 early-stage breast cancer patients enrolled with node-negative or one to three positive lymph node disease
    • 112 cancer centers across nine countries
    • Extensive collaboration with independent cancer research organizations such as the European Organization for the Research and Treatment of Cancer (EORTC) and Breast International Group (BIG)
    • First prospective translational research study in breast cancer of this magnitude
      [1]

 

WHAT IS MAMMAPRINT?

The MammaPrint test analyzes 70 genes in a patient’s breast cancer sample and provides a definitive Low Risk or High Risk of recurrence result based on the signature, or “fingerprint” of the tumor’s genes activity. Risk of recurrence testing with MammaPrint provides valuable information on the potential ability for a patient’s breast cancer’s to spread to other parts of the body (metastasis), which helps physicians and their patients with the treatment decision making plan.
 

WHAT WAS MAMMAPRINT’S ROLE IN MINDACT?

The MINDACT study looked at the role and utility of Agendia’s MammaPrint as a tool for assessing the risk of recurrence and the need for chemotherapy based on a cancer’s gene profile.

Agendia’s suite of cancer tests (MammaPrint and BluePrint®) are designed to help physicians more accurately individualize and optimize breast cancer treatment.

 

WHY ARE THESE FINDINGS IMPORTANT?

  • The publication demonstrates that 46% of breast cancer patients considered for chemotherapy, whose tumors are classified MammaPrint Low Risk, have excellent survival without chemotherapy, and can thus be candidates to avoid this toxic therapy.1, pg. 717
  • MammaPrint could change clinical practice by providing critical prognostic information to aid in assessing patients’ risk for distant metastasis and potentially sparing over one hundred thousand women annually[2] with early-stage breast cancer worldwide from unnecessary toxicities and side effects from chemotherapy and creating considerable cost savings.
  • As demonstrated in the MINDACT trial, MammaPrint is now the only FDA-cleared breast cancer prognostic test with the highest level of evidence (1A) for its clinical utility to aid correctly identifying Low Risk patients.

 

HOW WAS AGENDIA INVOLVED IN THE TRIAL?

MINDACT is an extensive collaboration between Agendia, cancer research organizations such as the European Organization for the Research and Treatment of Cancer (EORTC) and the Breast International Group (BIG), academic cancer centers, pharmaceutical companies and patient advocacy organizations. The study looked at the use of the MammaPrint 70-Gene Breast Cancer Recurrence assay in diagnostic testing. Agendia will continue to collaborate with pharmaceutical companies, leading cancer centers and academic groups on additional clinical research in the pursuit of bringing more effective, individualized treatments within reach of cancer patients. Additional information on Agendia’s support of the trial can be found in the publication.1, pg 728

 

WILL THESE FINDINGS IMPACT GENOMIC TESTING IN THE CLINICAL SETTING?

The MINDACT findings add to the growing body of evidence supporting the use of the MammaPrint assay for breast cancer testing in the clinical setting.  MammaPrint could change clinical practice by substantially reducing the use of adjuvant chemotherapy among clinically high risk patients and sparing many women from aggressive treatment they will not benefit from.

 

HOW IS MAMMAPRINT DIFFERENT FROM OTHER TESTS?

  • Other test like the Oncotype DX Breast Cancer recurrence test, can result in 39%[3] to 67%[4] of patients having indeterminate recurrence scores (RS 11-30)[5], which does not provide physicians with clear treatment options for their patients. MammaPrint provides definitive Low Risk and High Risk results, no intermediate results.
  • MammaPrint is the first and only genomic breast cancer recurrence assay that has FDA 510(k) clearance for women of all ages. FDA 510(k) clearance of a laboratory developed test (LDT) like MammaPrint assures the effectiveness and safety through a rigorous validation process. Non-cleared LDTs (like the Oncotype DX test) have not gone through the FDA clearance process and medical claims have not been validated by the FDA.
  • MammaPrint tests more genes than any other breast cancer genomic assay and is the only breast cancer genomic assay proven superior to the standard of care, clinical-pathological risk assessment.

 

WHAT DO THE MINDACT FINDINGS MEAN FOR PATIENTS?

The MINDACT results provide the highest level of medical evidence (Level 1A) that using the MammaPrint genomic test could spare many patients from going through treatment with chemotherapy they would not benefit from. With the results from this study, patients and doctors can clearly and confidently know when chemotherapy is or is not part of optimal treatment planning for women with breast cancer.

 

WHICH PATIENTS ARE ELIGIBLE FOR AGENDIA TESTING?

Patients diagnosed with stage I or II invasive breast cancer that is lymph node negative or lymph node positive (up to 3 nodes) and tumors ≤5cm are eligible for Agendia testing. Unlike other assays, there are no restrictions on other factors such as hormone receptor status (ER/PR or HER2) or hormonal therapy prescription.

 

With this new evidence, how could the MammaPrint help women who are going through breast cancer diagnosis or chemotherapy today?

If a woman with Stage I or II breast cancer is being diagnosed today and considered high-risk by clinical-pathological factors, she can consult with her treating physician about getting a MammaPrint test to complement the clinical-pathological assessment. If the MammaPrint result is Low Risk, the patient and her doctor can consider to forgo the chemotherapy.

 

HOW MUCH DOES AGENDIA’S MAMMAPRINT COST FOR A PATIENT?

Our mission is to ensure all breast cancer patients have access to important and clinically relevant molecular diagnostic testing empowering patients and physicians to make the most informed treatment decisions.

Agendia bills patient’s insurance companies directly for all services. Many insurance carriers cover genomic testing for breast cancer. Like each patient, each case is unique, and the average out-of-pocket amount varies based on: type of insurance policy, insurance benefits, what portion of the patient’s deductible has been met and the patient’s co-ins amounts. MammaPrint has substantial insurance coverage, including Medicare and regional and national payers.

More background:

If you are a patient and interested in learning more about MammaPrint testing and insurance coverage, please call 888-363-7868, and one of our Patient Advocate Representatives will gladly assist you.

 

WHAT IS THE IMPORTANCE OF GENOMIC TESTING?

Traditionally, physicians have relied on clinical-pathological factors such as age, tumor size, tumor grade, lymph node involvement, and hormone receptor status (ER/PR/HER2/Ki-67) to make breast cancer treatment decisions. Genomic tests are advanced tools used to understand more about a patient’s breast cancer biology at the molecular level, particularly for a cancer that has not spread to other organs. These tests look at specific tumor genes to help find out what’s driving its growth. Genomic tests like MammaPrint help estimate the risk of cancer recurrence in the years after diagnosis and predict whether certain treatments will be helpful to reduce the risk of cancer recurrence or metastasis (e.g. chemotherapy).

 

 About MINDACT

MINDACT is a prospective, randomized, phase III, controlled clinical trial that investigates 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 enrolled in the trial, across 112 centers in nine countries. Patients were categorized as low or high risk for tumor recurrence in two ways: first, through analysis of tumor tissue using MammaPrint; and second, using Adjuvant! Online, a tool that calculates risk of breast cancer recurrence based on common clinical pathological factors. Patients characterized in both clinical and genomic assessments as low risk are spared chemotherapy, while patients characterized as high risk are advised chemotherapy. Those with discordant results were randomized to use either clinical or genomic risk (MammaPrint) evaluation for chemotherapy treatment.

MINDACT is a population based trial. A risk–benefit assessment and decisions with respect to the use of chemotherapy are highly variable among physicians and patients, and even national and international guidelines differ in their recommendations. Ultimately, the decision to receive or forgo chemotherapy (or any other treatment) lies with each patient who is properly informed about the potential side effects and the potential benefits of such treatment. For the same risk–benefit scenario, different patients may make different decisions. 1, pg. 727-28

 

About MammaPrint

MammaPrint is a FDA-cleared in vitro diagnostic test, performed in a single laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis.  The MammaPrint result is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. MammaPrint is not intended for diagnosis, or to predict or detect response to therapy, or to help select the optimal therapy for patients. Results should be taken in the context of other relevant clinical-pathological factors and standard practice of medicine.

 

About Agendia

Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with complex treatment decisions. Agendia’s breast cancer and colorectal cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE 70-gene breast cancer recurrence assay as well as BluePrint®, a molecular subtyping assay that provides deeper insight leading to more clinically actionable breast cancer biology.

In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. For more information, visit www.agendia.com.

 

 

[1] Cardoso F, van’t Veer LJ, et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
[2] Based on applying MINDACT risk data to: American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta: American Cancer Society; 2015. (online) and American Cancer Society. Breast Cancer Facts & Figures 2015-2016. Atlanta:
American Cancer Society, Inc. 2015.
[3] Carlson JJ, Roth JA. The impact of the Oncotype DX breast cancer assay in clinical practice: a systematic review and meta-analysis. Breast Cancer Res Treat. 2014 Jul; 146(1): 233.
[4] Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015; 373: 2005-14
[5] Oncotype clinical recommendations as recurrence score (RS) 0-17 = low risk (49%), RS 18-30 = intermediate risk (39%), and RS >30 as high risk (12% (Carlson JJ 2014). However, the recently published TAILORx study considers RS 0-10 = low risk (16%), RS 18-25=intermediate risk (67%), and RS >25 as high risk (17%) (Sparano JA 2015)