Agendia BV Release: NCCN Breast Cancer Guidelines Acknowledge MammaPrint’s Ability to Predict Prognosis

Respected Panel Cites RASTER, the Only Published Prospective Outcome Data of Its Kind, Which Demonstrates MammaPrint’s Ability to Identify Those Patients Who May Safely Forego Chemotherapy

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, a global molecular diagnostics company that develops and markets genomic diagnostic products, announced that its MammaPrint® breast cancer recurrence test has received further recognition in new guidelines from the National Comprehensive Cancer Network® (NCCN®).

“We are proud of this achievement and are confident it will lead to increased adoption of MammaPrint and its companion BluePrint® molecular subtyping assay.”

These newly issued guidelines affirm that the FDA-cleared MammaPrint test is “clinically validated for prediction of prognosis” of breast cancer in women of all ages and is not limited by estrogen receptor status. Furthermore, this clinical practice document cites published evidence underscoring MammaPrint’s position as the only breast cancer recurrence assay supported by peer-reviewed prospective outcome data.

“This expanded support for MammaPrint in the latest NCCN guidelines is further evidence that leading clinicians recognize the unique clinical data behind MammaPrint and the added value it provides physicians and their patients when considering adjuvant chemotherapy treatment,” said Jan Egberts, M.D., the company’s CEO. “We are proud of this achievement and are confident it will lead to increased adoption of MammaPrint and its companion BluePrint® molecular subtyping assay.”

The NCCN panel took special note of the prospective RASTER study, which concluded that patients classified as Low Risk for recurrence by MammaPrint had a highly favorable outcome. MammaPrint-identified Low Risk patients (85% of whom did not receive adjuvant chemotherapy) had a 97% distant-recurrence-free-interval at five years.

“A growing number of cancer experts recognize the contribution that MammaPrint can make, by providing clinically useful information about disease prognosis and risk of recurrence,” said oncologist Neil Barth, M.D., FACP, Agendia’s Chief Medical Officer. “This acknowledgment further supports the emerging realization that accurately establishing a patient’s risk of recurrence, without the limitations seen with other assays, brings significant value to the management of breast cancer patients. The specific mention of the RASTER study confirms the relevance of prospective outcome data when the test was used in a real-world setting.”

In contrast to other assays with limited or no FDA clearances, MammaPrint is the only assay cleared for patients of all ages and is not limited by estrogen receptor status. Additionally, unlike other assays, MammaPrint test results do not require that patients complete five years of endocrine therapy. MammaPrint has received six FDA clearances, including most recently for use in formalin-fixed paraffin embedded (FFPE) tissue.

Resources for further reference

• RASTER prospective outcome study and press release
• Independent comparison validates molecular subtyping (includes video)
• MammaPrint valid up to 25 years press release

About Agendia and MammaPrint

Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. For breast cancer, our offerings include MammaPrint as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, and TargetPrint®, an ER/PR/HER2 expression assay. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.

Agendia’s breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome. MammaPrint incorporates a larger panel of genes than any other commercially available test and provides an unambiguous result of “Low vs. High Risk’” for recurrence of a patient’s breast cancer. MammaPrint is available worldwide and has substantial insurance coverage, including Medicare, regional and national insurers in the U.S. encompassing an estimated 200 million lives.

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. It is also a critical partner in the ISPY-2 and the MINDACT trials. For more information, visit www.agendia.com.

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