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Agendia NGS MammaPrint BluePrint Kit Receives CE Mark

NEW YORK (GenomeWeb) – Agendia said today that it has received CE marking for its next-generation sequencing-based MammaPrint BluePrint kit for breast cancer recurrence risk testing and molecular subtyping, allowing the firm to commercialize the device in Europe.

The MammaPrint BluePrint kit is an RNA-sequencing based version of Agendia's existing MammaPrint and BluePrint tests, which are performed at the company's clinical laboratories in Irvine, California and Amsterdam. Agendia developed the NGS kit in partnership with Agilent Technologies, using that firm's SureSelect target enrichment system, and worked with Bluebee to add a secure data processing solution for clinicians.

MammaPrint analyzes 70 breast cancer recurrence-associated genes, yielding a binary low-risk or high-risk result. BluePrint analyzes 80 genes, classifying a patient's breast cancer into one of a handful of functional molecular subtypes. A kit version of the tests offers a solution for the more decentralized testing environment in European countries, where clinical and hospital labs may need to be able to perform assays themselves in-house.

"We look forward to collaborating with leading breast cancer centers to provide them with these tools, enabling them to offer breast cancer risk-of-recurrence testing in-house," Marjolaine Baldo, Agendia's commercial vice president for Europe, the Middle East, and Africa, said in a statement.

Agendia is not the only company in the breast cancer risk space that has focused on adapting its technology to a kit format. For example, Genomic Health is working with Biocartis to develop an in vitro diagnostic version of the Oncotype DX breast cancer test on Biocartis' Idylla platform.