The Agendia Breast Cancer Test Suite

Uncover More.

The biology of your breast cancer is unique. Identifying the most effective, tailored therapies for your tumor is called Personalized Medicine, which starts with Precision Science — which is what we do at Agendia.  Traditionally, physicians have relied on clinicalpathological factors such as age, tumor size, tumor grade, lymph node involvement, and hormone receptor status to make breast cancer treatment decisions. While this information is useful, The Agendia Breast Cancer Test Suite uncovers your hidden breast cancer biology, providing you and your physician more information to help determine the most appropriate treatments for your specific tumor. Please see the descriptions below to learn more about the Agendia Breast Cancer Test Suite.

MammaPrint. Answers, not ambiguity

MammaPrint® 70-Gene Breast Cancer Recurrence Assay

MammaPrint is the only breast cancer recurrence assay backed peer-reviewed, prospective outcome data. Unlike other tests, you are given definitive Low Risk and High Risk results, eliminating the uncertainty of an intermediate risk score which can affect up to 39% of patients tested.3 A Low Risk result means you have a 10%, or 1 in 10 chance of your cancer returning. A High Risk result means you have a 29%, or 3 out of 10 chance of it returning.9  These results are based on a 10-year follow-up of a reference group of patients who had no additional treatment. A Low Risk result doesn’t guarantee that your cancer will not recur, and a High Risk result doesn’t guarantee that your cancer will. These results, in addition to all other factors help you and your doctor make the most appropriate breast cancer treatment decisions.

BluePrint® 80-Gene Molecular Subtyping Assay

BluePrint molecular subtyping provides deeper insight into tumor pathways, uncovering your hidden tumor biology. 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 really driving the tumor’s behavior. Combined with MammaPrint, BluePrint will uncover if your breast cancer is Luminal-type (A or B), Basal-type, or HER2-type. These findings are important when determining the treatments that are most appropriate for your specific tumor.

A definitive Low Risk or High Risk result: No Intermediate category

Having easy-to-interpret, clinically actionable treatment information helps you and your clinician make the most appropriate treatment decisions.  MammaPrint’s binary results removes the ambiguity you get with other assays, which have been shown to be as high as 39% of patients tested.3

Strong Prognostic Power, proven long-term

A 25-year follow-up study to the original New England Journal of Medicine publication of MammaPrint showed that these results have durable, accurate, long-term prognostic value.  These results are the longest-term follow-up study of its kind.

“This remarkable long-term study demonstrates the ability of the 70-gene signature to accurately differentiate higher-risk from lower-risk women with regard to risk of recurrence and overall survival, at a time in their lives when breast cancer can have its most devastating impact on fertility, productivity, and capacity to fulfill child-rearing responsibilities,”

What To Ask Your Doctor

Ask your doctor to run the Agendia Breast Cancer Test Suite on your breast cancer.  These tests can be run on a sample of your tumor that was removed during biopsy or surgery and was embedded in paraffin for storage (FFPE tissue).  No new biopsy or surgical tissue sample is usually required.

If your doctor is unfamiliar with Agendia testing, please call Customer Care at 888-321-2732, and we can help connect them with a local Agendia Oncology Specialist.

Cleared by the FDA

With FDA clearance, have confidence in your results8

MammaPrint received FDA clearance in 2007 and was the first in vitro diagnostic multivariate index assay (IVDMIA) to be cleared by the regulatory agency.  An IVDMIA is a device that combines the values of multiple variables using an interpretative function (bioinformatics algorithm) to provide a single, patient specific result, that is intended for use in the diagnosis of disease and which provides a result whose derivation is non-transparent, and for that reason, cannot be independently derived or verified by the end user.

MammaPrint’s FDA clearance confers confidence in its safety and effectiveness, ensuring that the peer reviewed, published studies used in its development, validation and IVDMIA clearance have been evaluated by the United States Food and Drug Administration. The FDA label indicates that as a diagnostic tool, MammaPrint has a 98.9% degree of accuracy in classifying patients as Low Risk or High Risk and technical reproducibility of 98.5%.

MammaPrint’s FDA indication – patient eligibility in the USA

Breast cancer recurrence and/or metastasis is partly dependent on the activation and suppression of certain genes located within the primary breast tumor. The FDA cleared MammaPrint profile is a fresh/FFPE tissue based genomics test which uses the latest microarray technology to analyze a patient’s breast tumor biology to predict whether existing cancer has the ability to metastasize. This 70-gene profile is validated as an independent indicator for breast cancer prognosis for women with lymph node-negative, estrogen receptor positive breast cancer and estrogen receptor negative disease.

Ask your doctor if the MammaPrint test is right for you.

 

Interpreting Your Test Results

Agendia provides a summary page designed for patients to help understand their individual results and have a meaningful discussion with their doctor about treatment options.

  • The first section is the MammaPrint result which provides you a definitive Low Risk or High Risk, risk of recurrence result, eliminating the ambiguous intermediate result you can get with other tests.
  • The second section is the BluePrint molecular subtyping result.  This looks deeper than traditional methods and provides more information on which gene pathways are really driving a tumor’s growth.

These results, combined with all other factors help you and your doctor make the most appropriate, personalized treatment decisions.

Participate in a clinical registry

Current Clinical Registry Trials

Agendia’s extensive clinical studies and research collaborations have produced numerous retrospective and prospective validation publications over the past decade.  Recently published studies further support the prognostic and predictive clinical utility of MammaPrint for early stage breast cancer patients, and large, multi-institutional clinical trials, such as MINDACT and ISPY-2, can be expected to expand the assay’s clinical importance and indications for use. Agendia recently published the results from the first ever prospective outcomes study for a breast cancer recurrence assay (RASTER) which indicated that Low Risk patients may safely forgo chemotherapy with a 97% DRFI (Distant Recurrence Free Interval) at 5 years.

Currently, Agendia is enrolling institutions and cancer centers worldwide in the following studies for Breast Cancer:

  • MINT: The Multi Institutional Neo Adjuvant Therapy MammaPrint Project trial (NCT01501487)
  • NBRST: Neo-adjuvant Breast Registry Symphony Trial (NCT01479101)
  • PROMIS: PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (NCT01617954)

 

Contact a customer care representative to learn more about participating in a clinical study.  They can be reached at 888-321-2732 or by email at customercare@agendia.com

Download Resources

Click on the links below to download helpful resource materials:

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

  • 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

    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

  • Better Breast Cancer Diagnosis with BluePrint

    TV report on a patient’s journey to a better breast cancer diagnosis. Dr. Mark Gittleman explains how new research with BluePrint and MammaPrint, which are molecular diagnostic tests, can refine and personalize a woman’s treatment for breast cancer.

    Share This Video

    Better Breast Cancer Diagnosis with BluePrint

    TV report on a patient’s journey to a better breast cancer diagnosis. Dr. Mark Gittleman explains how new research with BluePrint and MammaPrint, which are molecular diagnostic tests, can refine and personalize a woman’s treatment for breast cancer.

    Share This Video

  • 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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  • ABC News

    See how the MammaPrint results published from the RASTER study helped breast cancer patient Jennifer P. confidently avoid chemotherapy

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    ABC News

    See how the MammaPrint results published from the RASTER study helped breast cancer patient Jennifer P. confidently avoid chemotherapy

    Share This Video

  • Genomic testing for breast cancer patients

    Dr. Stephanie Akbari, MD, discusses how genomic testing is used to help guide treatment decisions for her patients

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    Genomic testing for breast cancer patients

    Dr. Stephanie Akbari, MD, discusses how genomic testing is used to help guide treatment decisions for her patients

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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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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