Agendia’s MammaPrint® and BluePrint® Breast Cancer Tests Selected by Unicancer for French Patients

Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announce that Unicancer, a hospital group entirely devoted to fighting cancer, has selected the MammaPrint® Breast Cancer Risk of Recurrence test and BluePrint® Molecular Subtyping test for use in its 18 French Comprehensive Cancer Centers (FCCC).

The successful tender includes both Agendia’s centralized laboratory service which enables physicians to send their patient’s tumor specimen for analysis using the MammaPrint and BluePrint tests at the Company’s CLIA-certified and CAP-accredited laboratories in Amsterdam, the Netherlands, and the next-generation sequencing-based MammaPrint BluePrint Kit. The decentralized MammaPrint BluePrint Kit can be run in-house to optimize the use of a center’s existing instrument. It obtained the CE mark and was launched in March following co-validation projects with Institut Curie in France, and UZ Leuven in Belgium.

Dr Marjolaine Baldo, VP Commercial, EMEA, at Agendia said: "In Europe, one in eight women will be diagnosed with breast cancer in her lifetime.(1) At Agendia we are dedicated to helping their physicians better tailor their treatment through the extra genomic insight provided by MammaPrint and BluePrint.

"Unicancer’s selection of MammaPrint and BluePrint as recommended diagnostic tools for 18 prestigious cancer centers is a significant milestone. It is a great step forward towards enabling access to the benefits of precision oncology for all women in France. The clinical utility of MammaPrint is supported by the highest level of evidence thanks to the MINDACT trial in which the FCCC played a significant part, enrolling 2,071 French patients which comprises almost a third of the total patients within the trial."(2)

MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a binary low or high Risk of cancer recurrence result, while BluePrint analyzes 80-genes which classify a patient’s breast cancer into functional molecular subtypes. 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.

 
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 patients’ 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 BluePrint®
BluePrint is an 80-gene complementary test provided with MammaPrint which allows functional molecular subtyping of a breast cancer sample into three distinct subtypes: Luminal-type, HER2-type and Basal-type, each with marked differences in long-term outcome and response to neoadjuvant chemotherapy.

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.

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