Breast cancer kit co-validation study

5th December 2017

Personalised medicine and molecular cancer diagnostics expert Agendia and Institute Curie in Paris, France, a leading player in the fight against cancer, have announced 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 tumor 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 from Agendia, said: “By adding a decentralised solution to our portfolio we can offer prestigious European cancer centres such as 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 highly innovative and one of the most prestigious cancer centres 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.”





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