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Agendia, Institut Curie ink partnership for MammaPrint BluePrint Breast Cancer Kit co-validation study

Irvine, California
Wednesday, December 6, 2017, 18:00 Hrs  [IST]

Agendia, a world leader in personalized medicine and molecular cancer diagnostics, and Institute Curie in Paris, France, a leading player in the fight against cancer, announce a co-validation partnership for Agendia’s new in vitro diagnostic (IVD) MammaPrint BluePrint Breast Cancer Risk of Recurrence and Molecular Subtyping Kit.

The co-validation study will demonstrate the performance of this new kit version of the MammaPrint and BluePrint tests in the decentralized setting ahead of the CE-marking and launch of the Kit in Europe early next year. Decentralized testing will enable additional European cancer centers to adopt the test in-house.

The objective of the study is to compare the processing of breast tumour samples at Institut Curie’s Diagnostics Core Facility using the new next-generation sequencing (NGS)-based MammaPrint BluePrint Kit, to the CE-marked microarray-based test performed at Agendia’s central laboratory in Amsterdam.

Tumour samples from patients enrolled in the study will be tested using the commercially-available microarray-based tests at Agendia. The Low Risk or High Risk result will be provided to Institute Curie’s clinical team to help in treatment management decisions. The Institute’s pathology and diagnostics team will also run the same sample in their laboratory using the NGS-based MammaPrint BluePrint Kit to ensure that the results are concordant.

Dr. Marjolaine Baldo, commercial vice president EMEA, at Agendia, said: “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.

“Institut Curie is a highly innovative and one of the most prestigious cancer centers in Europe and we are excited by the possibilities of this collaboration. This partnership demonstrates the demand for and support of a MammaPrint BluePrint kit-based solution.”

Amaury Martin, Head of Institut Curie Technology Transfer and Industrial Partnerships Office and Director of the Institut Carnot Curie Cancer said: "This partnership with Agendia on the validation of the MammaPrint BluePrint Kit marks a new stage in the collaboration between Institut Curie and Agendia. 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% of the hospital activity of the Institute and is regularly cited in the list of the best hospitals in France.

“The work carried out at Institut Curie in this area benefits from a unique fundamental and translational research ecosystem with state-of-the-art teams. 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."

In June 2017, Agendia announced an agreement to extend its relationship with Agilent Technologies Inc. to develop an RNA sequencing-based kit version of its existing MammaPrint and BluePrint tests which are currently performed centrally at the Company’s CLIA-certified and CAP-accredited laboratories in Irvine, CA and Amsterdam.

MammaPrint is an in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. MammaPrint is cleared by the US FDA and carries the CE Mark, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.

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.

The Institut Curie, a leading player in the fight against cancer, combines a leading French research center in oncology and a state-of-the-art hospital group that treat all types of cancer, including the rarest.


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