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 in the US at 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

1. How can I order Agendia testing?

Only a licensed healthcare provider (i.e. surgeon, medical oncologist, radiation oncologist, pathologist) can submit an order request for genomic testing. Ask your doctor to order the Agendia Breast Cancer Test Suite for your breast cancer. Local Agendia Molecular Oncology Specialists can assist you and your doctor with the ordering process.

2. Who is eligible for the Agendia Breast Cancer Test Suite?

Patients diagnosed with stage I or II invasive breast cancer that is lymph node negative or lymph node positive (up to 3 nodes) and < 5cm, are eligible for Agendia Breast Cancer testing. Unlike other assays, 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.

3. What will the MammaPrint test results show?

MammaPrint is a 70-gene test that will assess your cancer’s risk of recurrence, in other words, how likely the cancer is to return in the future. You are given definitive results, either a Low Risk or High Risk result, with no intermediate or indeterminate results which are common with other genomic tests. In patients with the most common type of breast cancer (hormone receptor positive, HER2 negative, lymph node negative [ER+ / HER2- / LN -]) 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 factors, will help you and your doctor make the most appropriate breast cancer treatment decisions.

4. What if I am in the Low Risk group?

According to the MINDACT study, if you are Low Risk by MammaPrint, you have a low risk of the cancer returning and there is little to no benefit of undergoing chemotherapy treatment. Patients that were Low Risk had an average of 2.2% risk of recurrence at 5 years, on hormonal therapy alone (average risk of recurrence for ER+ / HER2- / LN- patients).1

5. What if I am in the High Risk group?

If you are High Risk by MammaPrint, you have a higher risk of the cancer returning and studies have shown a 50% relative benefit of adding chemotherapy (Knauer et al, 2010). In the MINDACT study, patients that were High Risk had an average of 5.4% risk of recurrence at 5 years with chemotherapy in addition to hormonal therapy (average risk of recurrence for ER+ / HER2- / LN- patients).1
High Risk patients can be further divided into subtypes, which can refine your treatment plan. These subtypes provide additional information about what your tumor may be best responsive to: hormone therapy, chemotherapy, targeted therapy or a combination.

6. 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. Combined with MammaPrint, 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

7. 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 is the first and only FDA 510(k) cleared breast cancer recurrence assay for women of all ages and it is the only breast cancer recurrence assay that has been fully prospectively validated. BluePrint molecular subtyping is the most widely available molecular subtyping assay that helps identify your potential level of responsiveness to chemotherapy more accurately than IHC/FISH, with better correlation to long-term clinical treatment outcomes.2  MammaPrint and BluePrint can be ordered together or individually

8. 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 company directly throughout the US. Based on your specific benefit level, the insurance company may choose to pay a portion or all of the cost of the tests run by Agendia. You may be responsible for any co-insurance, co-pay, or deductible expenditure per your health insurance plan terms. Please give us a call us and one of our dedicated Patient Advocates will work with you and your insurance to find out your specific coverage details. Agendia’s Patient Advocates can be reached at 888-363-7868 or by email at billing@agendia.com.

  • For Canada, Latin America, and Oceania, please contact Customer Care in the US at 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.

9. 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 with patient 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 at 888-363-7868 or by email at billing@agendia.com.
  • For Canada, Latin America, and Oceania, please contact Customer Care 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 20 462 1500 or customerservice@agendia.com.

10. How long does it take to get results?

On average, results are provided within 10 business days.

11. 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 the patient’s 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 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.

12. What is the MINDACT study and what did the study find?

MINDACT1 is a practice changing clinical trial with the highest level of evidence, Level 1A, supporting the MammaPrint assay. This assay allows doctors to determine if patients can achieve distant metastasis free survival without the use of chemotherapy.
There were 6693 early-stage breast cancer patients who participated in the study. Patients were enrolled from 2007-2011 and were evaluated by both standard clinical factors (such as tumor size, nodal status, ER/PR/HER status) as well as genomic testing with MammaPrint. The study investigated several clinical questions but the primary analysis showed that a woman with high risk clinical factors (i.e. positive lymph nodes, tumors >2cm, grade 2 or 3) and who was identified as Low Risk by MammaPrint, had no clinically meaningful benefit of undergoing chemotherapy treatment. In the MINDACT trial, MammaPrint results helped reduce overtreatment with chemotherapy in 46% of the women tested. MammaPrint is the only breast cancer recurrence assay on the market with both Level 1A evidence and FDA 510(k) clearance for women of all ages, giving physicians and patients absolute assurance in their MammaPrint results.

13. Where was the MINDACT study performed?

The study was performed in 112 different institutions across 9 countries throughout Europe by the European Organisation for Research and Treatment of Cancer (EORTC). MINDACT is an independent EORTC trial and MammaPrint was specifically chosen as the genomic assay for the trial.

14. If a patient has already started chemotherapy, can they still get a MammaPrint test and could that lead to termination of their treatment?

Yes, the patient would still be able to ask their physician to order a MammaPrint test. The decision on whether to continue or discontinue treatment would be a conversation between the patient and their physician.

15. If a patient has already had an Oncotype DX test, would my doctor be able to order a MammaPrint test

Yes, Oncotype DX test results come back with intermediate or indeterminate results between 39%3 and 67%4 of the time depending on the study. In these cases, the need for chemotherapy is uncertain. Physicians can order a MammaPrint test to get either a Low Risk or High Risk result to assist in chemotherapy treatment decisions. Please contact our Patient Advocate representative for further information.

  • In the US, Agendia’s Patient Advocates can be reached at 888-363-7868 or by email at billing@agendia.com.
  • For Canada, Latin America, and Oceania, please contact Customer Care 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 20 462 1500 or customerservice@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.

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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

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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.

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    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