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Diagnostics Personalized Medicine Oncology Reimbursement

 News Release - May 1, 2018

Agendia's MammaPrint(R) Receives Positive Coverage Decisions from Three Major Private Healthcare Insurers

Decisions from Aetna, Cigna and UnitedHealthcare followed the latest update to the American Society of Clinical Oncology (ASCO) guidelines recommending MammaPrint® Breast Cancer Risk of Recurrence Test for certain breast cancer patients

Majority of U.S. breast cancer patients will now be covered for MammaPrint, which could result in significant cost savings


IRVINE, Calif. and AMSTERDAM, May 1, 2018 -- (Healthcare Sales & Marketing Network) -- Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announced that Aetna, Cigna and UnitedHealthcare (part of the UnitedHealth Group), three of the largest private healthcare insurers in the U.S., have issued positive coverage decisions for the MammaPrint® Breast Cancer Risk of Recurrence test. MammaPrint offers many cost-effective benefits, including potentially reducing the number of breast cancer patients treated with chemotherapy, managing subsequent, often serious side effects, and other factors, such as lost working time.1

The decision by these three leading healthcare insurers, who cover more than 85 million people in the U.S. and internationally, substantially increases MammaPrint's total coverage in the U.S. This enables the majority of women with breast cancer in the country to access the test and benefit from personalized treatment.

This follows a dedicated update to the American Society of Clinical Oncology (ASCO)'s breast cancer clinical practice guidelines in July 2017. The update, based on a review of the findings of the landmark MINDACT trial, named MammaPrint as the only test of its kind recommended to inform treatment decisions for both lymph node-positive and lymph node-negative breast cancer patients.2,3

MammaPrint analyzes a patient's tumor sample using a panel of the 70 genes most associated with breast cancer recurrence to assign a genomic low risk or high risk of distant metastasis. A MammaPrint Low Risk result helps physicians identify patients unlikely to see any significant benefit from chemotherapy, aiding in effective, informed and personalized treatment management decisions which reduce the risk of overtreatment and the associated side effects.

Dr. William Audeh, Chief Medical Officer at Agendia said:

"The positive coverage decisions by these major healthcare insurers echo the rapidly increasing adoption of MammaPrint among U.S. physicians who recognize the value of the test to personalize and, in many cases, deescalate treatment for early breast cancer. MammaPrint provides physicians with a binary low risk or high risk of recurrence result that has considerable quality of life and cost-saving implications."

The MINDACT trial found that almost 50 percent of patients initially identified as at high risk of their cancer recurring using clinical and pathological factors and therefore candidates for chemotherapy, were in fact low risk according to the MammaPrint test and unlikely to benefit from it. Results of a recent study presented at the European Breast Cancer Conference (EBCC-11) in March found that using MammaPrint to identify these low risk patients and to adapt their treatment accordingly could result in an annual cost saving in the U.S. of $1.5 billion, based on the findings from MINDACT.1

About MammaPrint®

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patient's risk for distant metastasis. The device is FDA-cleared and CE-marked, enabling use in the European Union. The MammaPrint® BluePrint® next-generation sequencing-based kit is a CE-marked device currently available for use in cancer centers in select regions of the world.

MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient's response to therapy.

About MINDACT

MINDACT is 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 were enrolled in the trial, across 112 centers in nine countries.

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 analyzing the complete human genome. Our offerings include the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test, both on microarray technology, and the new MammaPrint BluePrint Recurrence and Molecular Subtyping test, on NGS technology.

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.

1 Retél V. Cost-effectiveness of Genomic Testing. Presentation at European Breast Cancer Conference (EBCC). March 2017; Barcelona, Spain

2 Krop I, Ismaila N, Andre F et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. DOI: 10.1200/JCO.2017.74.0472 Journal of Clinical Oncology – published online before print July 10, 2017

3 Cardoso 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.


Source: Agendia

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