FAQs:

Agendia Customer Care is always here to help. For any additional questions or information, please contact one of our friendly representatives:

  • For US, Canada, Latin America and Oceania, please contact Customer Care toll-free in the US at 888-321-2732, Monday through Friday, 6:00 am to 5:00 pm Pacific Time, or customercare@agendia.com
  • For Europe, Asia or South Africa, please contact Customer Service in The Netherlands at +31 20 462 1500, Monday through Friday, 0830 to 1700, or customerservice@agendia.com

1. WHAT IS GENOMIC TESTING?

Genomic testing looks at the specific genes in a tumor to find out what is driving its growth.  Gene expression testing helps design a personalized medical treatment plan tailored to your specific needs.  Genomic tests are not the same as genetic tests.  Genetic tests, in contrast, are used to determine your inherited risk or hereditary predisposition for cancer.

Your doctor will assess many factors prior to determining your treatment plan, including the size of the tumor, lymph node involvement, and the hormone receptor status of your cancer. These factors, along with your tumor’s genomic profile, can help you and your physician make the most informed treatment decisions for your specific type of cancer.

2. HOW CAN I ORDER AGENDIA TESTING?

Only a licensed healthcare provider (i.e., surgeon, medical oncologist, radiation oncologist, pathologist) can submit a test request order.  Ask your doctor if the Agendia Breast Cancer Test Suite is right for you.  Local Agendia Molecular Oncology Specialists can assist you and your doctor with the ordering process, or contact our Customer Care team to locate the ordering doctors near you.

3. IS MAMMAPRINT® RIGHT FOR ME?

Only a licensed healthcare professional is qualified to determine if the MammaPrint test is right for you.  The test is intended for use in breast cancer patients, with Stage I or Stage II disease, tumor size <5 cm and lymph node negative disease.  The test is indicated for use by healthcare providers as a prognostic marker along with other clinicopathological factors.  It is not intended to determine the outcome of disease, nor to suggest an individual’s likely response to therapy.

Unlike other similar genomic tests, the Agendia Breast Cancer Suite of tests has no restrictions on other factors such as hormone receptor status (estrogen receptor/progesterone receptor), HER2 status, or hormonal therapy prescription.

4. IS MAMMAPRINT IN CLINICAL PRACTICE GUIDELINES?

Yes, MammaPrint is included in numerous clinical practice guidelines by worldwide recognized societies. These guidelines help to provide healthcare providers with a set of recommendations for the most current standard of cancer care. The societies include:  American Society of Clinical Oncology (ASCO), St Gallen, American Joint Committee on Cancer (AJCC), European Society of Medical Oncology (ESMO), European Group on Tumor Markers (EGTM), German Gynecological Oncology Group (AGO), and National BorstKanker Overleg Nederland (NABON).

5. WHAT WILL THE MAMMAPRINT TEST RESULTS SHOW?

MammaPrint is a 70-gene test that will assess your risk of cancer recurrence. in other words, how likely the cancer is to return.  You are provided either a Low Risk or High Risk result, with no intermediate or inconclusive results (which can occur with other tests).  In patients with the most common type of breast cancer (hormone receptor positive, HER2 negative, lymph node negative [ER-positive / HER2-negative / LN-negative]) a Low Risk MammaPrint result showed an excellent 97.8% chance of being metastasis free at 5 years with hormonal therapy alone (tamoxifen or aromatase inhibitor), with no significant benefit of adding chemotherapy.  In patients with a High Risk MammaPrint and treated with hormonal therapy and chemotherapy, these women had a 94.6% chance of being metastasis free at 5 years.  These results are based on the landmark MINDACT clinical trial and represent the average risk of recurrence for these two groups.1

A Low Risk result does not guarantee that your cancer will not recur.  A High Risk result doesn’t guarantee that your cancer will recur.  These results, in addition to all other clinical factors, will help you and your doctor make the most appropriate breast cancer treatment decisions.

6. WHAT IF I AM IN THE LOW RISK GROUP?

Based on data from the MINDACT Trial, if you are Low Risk by MammaPrint you are at low risk for cancer relapse and not likely to show a significant benefit from chemotherapy.

As a Low Risk patient, you have an average of 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

7. WHAT IF I AM IN THE HIGH RISK GROUP?

Based on data from the MINDACT Trial, if you are High Risk, there is an average of 5.4% risk of recurrence at 5 years with chemotherapy in addition to hormonal therapy (average risk of recurrence for ER-positive / HER2-negative / LN-negative patients).1

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

8. WHAT WILL THE BLUEPRINT® RESULTS SHOW?

BluePrint is an 80-gene test that uncovers your tumor’s functional molecular subtype.  Molecular subtyping informs your doctor about how the tumor is functioning underneath the surface.  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 behavior.  BluePrint will determine if your breast cancer is Luminal-type (A or B), Basal-type, or HER2-type.  These findings are important when deciding which treatment is most appropriate for your specific tumor.

9. WHY SHOULD I USE MAMMAPRINT AND BLUEPRINT TOGETHER?

MammaPrint and BluePrint provide you and your doctor with a deeper insight into the tumor pathways by uncovering hidden tumor biology.  By combining risk of recurrence, with molecular subtyping, you get a clearer picture of how your breast cancer is functioning, leading to a better-informed treatment assessment.  MammaPrint was the first and currently only U.S.FDA cleared breast cancer recurrence test for women of all ages and the only breast cancer recurrence test to date that has been validated in a prospective study.  BluePrint molecular subtyping helps identify your potential level of responsiveness to chemotherapy, with better correlation to long-term clinical treatment outcomes.2  MammaPrint can be ordered alone, or in combination with BluePrint;  BluePrint is not offered independently.

10. How long does it take to get results?

On average, results are provided to your doctor within 10 business days.

11. WILL MY INSURANCE COVER THE COST OF THE TEST?

In the United States and Puerto Rico, Agendia is contracted with Medicare and many other large national and regional health plans, covering over 200 million lives.  Agendia will bill your insurance provider directly on your behalf throughout the US.  Based on your specific benefit level, your insurance provider may choose to pay a portion or all of the cost of the tests.  You will be responsible for any co-insurance, co-pay, or deductible expenditure per your specific health insurance plan’s terms.  Please contact us and one of our dedicated Patient Advocates will work with you and your insurance provider to clarify your specific coverage details.  Agendia’s Patient Advocates can be reached toll-free in the U.S. at 888-363-7868 or by email at billing@agendia.com.

For Canada, Latin America, and Oceania, please contact Customer Care toll-free in the U.S. at (+001) 888-321-2732 or customercare@agendia.com.

For Europe, Asia, or South Africa, please contact Customer Service in The Netherlands at +31 20 462 1500 or customerservice@agendia.com.

12. WHAT IF I DON’T HAVE INSURANCE OR MY HEALTH PLAN WON’T COVER THE TEST?

Please contact us to inquire about programs that Agendia offers that might assist you with access to our tests or to learn more about how Agendia can assist with an insurance appeal.

In the US, Agendia’s Patient Advocates can be reached toll-free in the U.S. at 888-363-7868 or by email at billing@agendia.com.

For Canada, Latin America, and Oceania, please contact Customer Care toll-free in the U.S. at (+001) 888-321-2732 or customercare@agendia.com.

For Europe, Asia, or South Africa, please contact Customer Service in The Netherlands at +31 (0)20 462 1510 or customerservice@agendia.com.

13. HOW COULD THE MAMMAPRINT TEST HELP IF YOU ARE GOING THROUGH BREAST CANCER DIAGNOSIS OR CHEMOTHERAPY TODAY?

If you are diagnosed with Stage I or II breast cancer today and considered high-risk by clinical-pathological factors, you can consult with your treating doctor about getting a MammaPrint test to complement the clinical-pathological assessment.

14. IF YOU HAVE ALREADY HAD AN ONCOTYPE DX TEST, WOULD YOUR DOCTOR BE ABLE TO ORDER A MAMMAPRINT TEST?

Yes, your doctor can always order a MammaPrint test for you.
When an Oncotype DX test comes back with intermediate or Inconclusive results, which occurs between 39%3 and 67%4 of the time depending on the study, you may choose to speak with your doctor about the MammaPrint test which will provide either Low Risk or High Risk results. To clarify your specific insurance coverage, please contact an Agendia Patient Advocate representative for more information.

In the US, Agendia’s Patient Advocates can be reached toll-free at 888-363-7868 or by email at billing@agendia.com .

For Canada, Latin America, and Oceania, please contact Customer Care toll-free in the US at (+001) 888-321-2732or customercare@agendia.com .

For Europe, Asia, or South Africa, please contact Customer Service in The Netherlands at +31 (0)20 462 1510 or customerservice@agendia.com .

About MINDACT

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 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 were potentially spared chemotherapy, while patients characterized as high risk were advised to consider chemotherapy.  Those with discordant results were randomized to use either clinical or genomic risk (MammaPrint) evaluation for chemotherapy treatment.

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

About MammaPrint

MammaPrint is a FDA-cleared, CE-marked 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 BluePrint

BluePrint is a laboratory developed test (LDT) in the US, performed exclusively by Agendia, and is designed to classify breast cancer into one of three molecular subtypes: Luminal-type, HER2-type, or Basal-type.  The classification is based on genomic assessment of 80-genes that uncover the functional molecular pathways of a patient’s tumor. The BluePrint result when combined with MammaPrint will provide patients and their doctors more information about a cancer’s genomic makeup that can help guide the most appropriate treatment strategies.

About Agendia

Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions.  Agendia’s breast cancer tests were developed using an unbiased gene selection by analysing the complete human genome.

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 on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.

What is genomic testing?

Genomic tests look at your specific tumor’s genes, to help find out what’s driving its growth.  Using gene expression testing to help design a tailored treatment plan is called personalized medicine.  These are not the same as genetic tests that determine your inherited risk or hereditary predisposition for cancer.

Your physician will assess many factors prior to determining your treatment plan, including the size of the tumor, lymph node involvement, and the hormone receptor status of your cancer.  These factors, along with your tumor’s genomic profile, can help you and your physician make the most informed treatment decisions for your specific type of cancer.

Your tumor is unique, your treatment should be too

  • Julieta

    Julieta was originally told she needed chemotherapy but wanted to avoid it.

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    Julieta

    Julieta was originally told she needed chemotherapy but wanted to avoid it.

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  • Mary

    Mary is confident knowing that she really needed chemotherapy.

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    Mary

    Mary is confident knowing that she really needed chemotherapy.

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  • Nicole

    Nicole talks about how MammaPrint may have saved her life by letting her doctors know that her tumor was high risk even though it appeared to be low risk by traditional parameters.

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    Nicole

    Nicole talks about how MammaPrint may have saved her life by letting her doctors know that her tumor was high risk even though it appeared to be low risk by traditional parameters.

    Share This Video

  • Dealing with an "intermediate" breast cancer recurrence score

    Breast cancer patient Cari G. explains how MammaPrint’s definitive results helped her and her physician choose the best course of treatment when she was initially given an ambiguous Intermediate result from the 21-gene assay

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    Dealing with an "intermediate" breast cancer recurrence score

    Breast cancer patient Cari G. explains how MammaPrint’s definitive results helped her and her physician choose the best course of treatment when she was initially given an ambiguous Intermediate result from the 21-gene assay

    Share This Video

  • Sherri

    Sherri found it reassuring when her MammaPrint test came back and showed that she had a low risk of recurrence.

    Share This Video

    Sherri

    Sherri found it reassuring when her MammaPrint test came back and showed that she had a low risk of recurrence.

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  • Breast cancer is heterogeneous disease

    Dr. Rene Bernards, PhD, co-developer of MammaPrint® discusses how breast cancer biology drove the discovery of the 70-Gene Breast Cancer Recurrence Assay

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    Breast cancer is heterogeneous disease

    Dr. Rene Bernards, PhD, co-developer of MammaPrint® discusses how breast cancer biology drove the discovery of the 70-Gene Breast Cancer Recurrence Assay

    Share This Video

JOIN A SUPPORT GROUP

Learn more about breast cancer treatment by visiting www.KnowYourBreastCancer.com or connect with a support group through the Symphony Sisterhood on Facebook