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University Hospitals Leuven Joins Validation Effort for Agendia MammaPrint, BluePrint IVD Kit

NEW YORK (GenomeWeb) – Agendia said today that Belgium's University Hospitals Leuven has agreed to participate in a co-validation effort 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, which will allow cancer centers and other customers to run these tests on existing next-generation sequencing instruments in their own laboratories, rather than sending them to Agendia for centralized processing.

UZ Leuven will join the Institut Curie, whose participation Agendia announced earlier this week, in helping to validate the new NGS kits. Like Institut Curie, UZ Leuven will process breast tumor samples from patients enrolled in the study using the NGS-based MammaPrint BluePrint Kit. Agendia will then compare these results with those from the existing microarray-based MammaPrint test, performed at the company’s Amsterdam CLIA-certified and CAP-accredited laboratory.

Marjolaine Baldo, commercial vice president for Europe, the Middle East, and Africa at Agendia, said in a statement that the co-validation is "one of the final steps to complete before we launch our CE-marked MammaPrint BluePrint Kit in 2018."