Agendia’s MammaPrint prepares for Europe

Company teams up with Institut Curie for kit validation

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AMSTERDAM & PARIS—Agendia, the company behind a successful suite of breast cancer tests, is partnering with Paris-based Institut Curie to co-validate its new in-vitro diagnostic next-generation sequencing (NGS) MammaPrint BluePrint Breast Cancer Risk of Recurrence and Molecular Subtyping Kit.
The MammaPrint BluePrint Kit is designed for use in women with early-stage breast cancer to help personalize treatment approaches by identifying patients who are unlikely to benefit from chemotherapy. The study will compare test results of the same samples from commercially available microarray-based tests conducted at Agendia’s Amsterdam facility with those run at the Institut Curie’s Diagnostics Core Facility using the MammaPrint kit.
Agendia’s MammaPrint is a 70-gene breast cancer test that predicts the chances of an early-stage tumor’s recurrence, while BluePrint is an 80-gene molecular subtyping assay. MammaPrint received FDA approval in 2007 and is used in the United States to provide the functional molecular subtype of a woman’s breast cancer. The MammaPrint RNA “signature” identified with the test serves as a strong determinant if a tumor will come back, and can predict the result of contemporary, commonly used chemotherapy and targeted therapy regimens.
Data generated through the test offers oncologists more options to reduce treatment toxicity—and costs—for millions of women diagnosed with breast cancer annually.
“Predicting which patients will benefit the most from costly and potentially toxic therapies—and which patients can safely forego them—is a critically important part of improving breast cancer care,” says Agendia CEO Mark Straley. “[Our] assays continue to demonstrate that they can help physicians make the most personalized and most current predictive treatment decisions for each breast cancer patient.”
The co-validation study will demonstrate the performance of the new kit version of the MammaPrint and BluePrint tests in preparation for the kits receiving CE-marking and launching in Europe later this year. Low-risk and high-risk results from the microarray-based tests will be provided to  Institut Curie’s clinical team to compare against the kits’ results, and to assist in treatment planning for patients enrolled in the study.
“This partnership is a strong endorsement of our decentralized approach, and we are in contact with a number of [European] cancer centers interested in the benefits of offering MammaPrint and BluePrint in their laboratories,” asserts Dr. Marjolaine Baldo, commercial vice president EMEA at Agendia. “By adding a decentralized solution to Agendia’s portfolio, we can offer prestigious European cancer centers like Institut Curie the opportunity to both run the MammaPrint and BluePrint tests in a kit form, and to take advantage of the NGS instruments they already have in place. This benefits patients by bringing these valuable tests closer to them, expanding access to the benefits of personalized breast cancer treatment approaches.”
The co-validation partnership with Institut Curie is an important final step as Agendia prepares for the European launch of the NGS-based MammaPrint BluePrint Kit during the second quarter of this year.
In December 2017, Agendia also announced a partnership with UZ Leuven in Belgium as a second European cancer center to co-validate the kit. The study will follow the same procedure as for Institut Curie, with UZ Leuven processing breast tumor samples using the NGS kit, which are compared with those from the microarray tests performed in Amsterdam.
According to Amaury Martin, head of the Institut Curie Technology Transfer and Industrial Partnerships Office and director of the Institut Carnot Curie Cancer, “The Institut Curie MC21 strategic plan has identified innovation around breast cancer as a major axis of medical-scientific research. Treatment of these cancers represents a little over 60 percent of the hospital activity of the Institute, which is regularly cited in the list of the best hospitals in France. The technologies developed by Agendia will fully benefit our patients, and their presence within the Institute opens the door to future collaborations to develop and validate predictive tests whose usefulness is undeniable in the course of care.”
Institut Curie’s 2015-2020 MC21 strategic plan aims at positioning the Institut Curie a reference for technology transfer in oncology. Faithful to the model conceived by Marie Curie in 1909, the institute says, “this new breath will strengthen the interactions between research and care, catalyzing the transformation of research findings into medical applications for maximum patient benefit.”

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