October 9, 2018

Agendia Announces Level 1 Inclusion of MammaPrint® Breast Cancer Test in Updated National Comprehensive Cancer Network® (NCCN) Guidelines

PRESS RELEASE

Agendia Announces Level 1 Inclusion of MammaPrint® Breast Cancer Test in Updated National Comprehensive Cancer Network® (NCCN) Guidelines

IRVINE, CALIF., U.S., AMSTERDAM, NETHERLANDS – 9 October 2018 – Agendia, Inc., a world leader in precision oncology, today announced that the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include the MammaPrint® 70-gene Breast Cancer Risk-of-Recurrence Test, which helps determine the likelihood breast cancer will recur in patients with estrogen receptor-positive breast cancer that is either lymph-node negative or positive (LN+ 1-3). With these updates, MammaPrint has received the broadest guidance of any genomic test, and is the only test of its kind with Level 1 evidence for both lymph-node negative and lymph-node positive disease.

The NCCN Guidelines, which are the recognized clinical standard for cancer care, are created by input from clinicians and researchers at leading cancer centers. The NCCN revises recommended practice guidelines according to current evidence with the ultimate goal of improving patient care and outcomes.

MammaPrint’s inclusion in the NCCN guidelines is based on data from the landmark clinical trial, MINDACT, a randomized, prospective, Phase III trial, which evaluated the clinical utility of the MammaPrint test. The study, published in the New England Journal of Medicine in 2016, found that almost 50 percent of patients initially identified with a high risk of their cancer recurring based on clinical and pathological factors and thus candidates for chemotherapy, were in fact Low Risk according to the MammaPrint test and unlikely to benefit from it.2

MammaPrint analyzes the 70 most important genes associated with breast cancer recurrence to classify each breast cancer patient into “Low Risk” or “High Risk” of developing metastases within the first 10 years after diagnosis.

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

“As we recognize this month that breast cancer is the most common cancer and second leading cause of death among women in the US, we appreciate the decision by the NCCN Panel to endorse the use of MammaPrint. This represents a future-forward shift in the use of genomic assays to equip physicians with tools to make data-driven, personalized decisions regarding the need for chemotherapy in ER+ breast cancer for all women, not just those with lymph-node negative disease.”

Mark Straley, Chief Executive Officer at Agendia said:
“We welcome these updated recommendations, which reinforce the clinical utility of the MammaPrint test and its importance to patients. We’re glad to see our test continue to receive inclusion in multiple influential cancer care guidelines – NCCN, ASCO and FDA-clearance represent the “triple crown” and acknowledge its unique value and ability to help thousands of women with early-stage breast cancer avoid potentially unnecessary treatments.” 

The updated NCCN guidelines mark the fifth positive international guideline decision for MammaPrint since 2017 following the guidelines from American Society of Clinical Oncology (ASCO), which recommends the MammaPrint test for clinical high risk, hormone receptor-positive, HER2-negative breast cancer, to inform decisions on withholding chemotherapy.

You can access the updated NCCN guidelines at www.nccn.org.

1 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

2 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.

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About MammaPrint

MammaPrint is an in vitro diagnostic medical device, performed as a testing service in a central laboratory, using the 70-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. 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 precision oncology 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. The company’s offerings include the MammaPrint Breast Cancer Risk-of-Recurrence Test, and the BluePrint Molecular Subtyping Test, both on microarray technology, whereas the new MammaPrint BluePrint Breast Cancer Recurrence and Molecular Subtyping Kit, is on NGS technology.

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.

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, visitwww.agendia.com. Follow Agendia, Inc. on Facebook, Twitter, or LinkedIn to keep up-to-date with the latest news.

Media Contacts

Agendia

Weber Shandwick

Heather Platisha

+1 (206) 576-5558

[email protected]