FAQs

FAQs 2016-11-29T16:34:14+00:00

Answers To Important Questions You May Have

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.

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.

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.  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-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 factors, will help you and your doctor make the most appropriate breast cancer treatment decisions.

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 distant recurrence at 5 years, on hormonal therapy alone (average risk of recurrence for ER-positive / HER2-negative / LN-negative patients).1

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-positive / HER2-negative / LN-negative 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.

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.

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.2MammaPrint and BluePrint can be ordered together or individually.

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

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.

On average, results are provided within 10 business days.

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.

MINDACT is a collaboration between Agendia, the European Organization for Research and Treatment of Cancer (EORTC) and the Breast International Group (BIG). A unique phase III prospective, randomized, controlled study of 6,693 patients across 112 European cancer centers, MINDACT provides the highest level of clinical evidence (Level 1A) and confirms the clinical utility of using Agendia’s MammaPrint 70-gene breast cancer recurrence assay to help predict clinical outcome in women with early-stage breast cancer.1

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

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.

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 MammaPrint result is Low Risk, the patient and her doctor can consider to forgo the chemotherapy.

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 in conjunction with clinical-pathological factors. 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.

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.1

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

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.

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.