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Institut Curie Joins Co-Validation Study for Agendia's MammaPrint, BluePrint Breast Cancer Kit

NEW YORK (GenomeWeb) – Agendia said today that Institut Curie has joined up as a co-validation partner for an in vitro diagnostic kit version of the company's MammaPrint and BluePrint breast cancer assays.

Agendia said this June that it was extending its relationship with Agilent Technologies to develop an RNA sequencing-based version of its existing MammaPrint and BluePrint tests that could be used by labs in a more decentralized testing setting.

In the study with Curie, Agendia will compare the results from samples processed at the institute's diagnostics core facility using the new NGS kit, to results from its existing CE-marked microarray-based test performed at Agendia's central laboratory in Amsterdam.

A confirmation of concordance between the two would then support the CE marking and launch of the kit in Europe early next year, Agendia said.

Participation in the co-validation study doesn't necessarily mean that Institut Curie will be a customer for the kits once CE marked, but Agendia Commercial Vice President EMEA Marjolaine Baldo said in a statement that the partnership "demonstrates the demand for and support of a MammaPrint BluePrint kit-based solution.”

Agendia is not alone in moving to a kit-based model that allows more decentralized testing in the European market. Genomic Health said this September that it had partnered with Biocartis to develop an IVD version of its Oncotype DX breast cancer assay on the firm's Idylla platform.