FAQs

FAQs 2017-11-16T20:13:49+00:00

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 <a href=”mailto:customercare@agendia.com”>customercare@agendia.com</a>

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 <a>customerservice@agendia.com</a>

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.

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.

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.

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).

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.<sup>1</sup>

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.

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).<sup>1</sup>

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).<sup>1</sup>

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.

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.

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.<sup>2</sup>  MammaPrint can be ordered alone, or in combination with BluePrint;  BluePrint is not offered independently.

On average, results are provided within 10 business days.

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 <a href=”mailto:customerservice@agendia.com”>customerservice@agendia.com</a>

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.
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In the US, Agendia’s Patient Advocates can be reached at 888-363-7868 or by email at <a href=”mailto:billing@agendia.com”>billing@agendia.com</a>.

For Canada, Latin America, and Oceania, please contact Customer Care in the US at (+001) 888-321-2732or <a href=”mailto:customercare@agendia.com”>customercare@agendia.com</a>.

For Europe, Asia, or South Africa, please contact Customer Service in The Netherlands at +31 20 462 1500 or <a href=”mailto:customerservice@agendia.com”>customerservice@agendia.com</a>.

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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.

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 .

MINDACT is a <strong>prospective, randomized, phase III, controlled clinical trial</strong> 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, <strong>6,693</strong> 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.<sup>1</sup>

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.<sup>1</sup>

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.

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.

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.

References

[1] Cardosa F, van’t Veer LJ, Bogaerts J 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] Glück, S., de Snoo, F., Peeters, J. et al. Breast Cancer Res Treat (2013) 139: 759. doi:10.1007/s10549-013-2572-4

[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.