Agendia, Irvine, Calif, and Institut Curie, Paris, have announced a covalidation partnership for Agendia’s new MammaPrint BluePrint breast cancer risk of recurrence and molecular subtyping kit.

The covalidation study will demonstrate the performance of the new kit version of Agendia’s MammaPrint and BluePrint tests in a decentralized setting, ahead of the CE marking and launch of the kit in Europe. Decentralized testing will enable additional European cancer centers to adopt the test in house.

The objective of the study is to compare testing performed at Agendia’s central laboratory in Amsterdam using the CE-marked microarray-based MammaPrint and BluePrint tests, to the processing of breast tumor samples at Institut Curie’s diagnostics core facility using the next-generation sequencing (NGS)-based MammaPrint BluePrint kit.

Tumor samples from patients enrolled in the study will be tested using the commercially available microarray-based tests at Agendia. To ensure that the test results are concordant, the Institut Curie’s pathology and diagnostics team will run the same samples in its laboratory, using the NGS-based MammaPrint BluePrint kit. The low-risk or high-risk results will be provided to the institute’s clinical team to help in treatment management decisions.

Marjolaine Baldo, PhD, Agendia.

Marjolaine Baldo, PhD, 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,” says Marjolaine Baldo, PhD, Agendia’s commercial vice president for Europe, the Middle East, and Africa. “This benefits patients by bringing these valuable tests closer to them, expanding access to the benefits of personalized breast cancer treatment approaches.”

“This partnership with Agendia on the validation of the MammaPrint BluePrint kit marks a new stage in the collaboration between Institut Curie and Agendia,” says Amaury Martin, head of the Institut Curie office of technology transfer and industrial partnerships and director of the Institut Carnot Curie Cancer.

Institut Curie has identified innovation centered on breast cancer as a major axis of its medical-scientific research. Treatment of these cancers represents a little over 60% of the hospital activity of the institute, which is regularly cited among 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,” says Martin. “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.”