The next-generation sequencing (NGS)-based MammaPrint BluePrint breast cancer recurrence and molecular subtyping kit from Agendia Inc, Irvine, Calif, has received the CE mark, enabling the company to commercialize the device in Europe.

Marjolaine Baldo, PhD, Agendia.

Marjolaine Baldo, PhD, Agendia.

“Obtaining the CE mark for the MammaPrint BluePrint kit is a huge milestone,” says Marjolaine Baldo, PhD, Agendia’s commercial vice president for Europe, the Middle East, and Africa. “For the first time, prestigious cancer centers acoss Europe will be able to run MammaPrint and BluePrint in their own labs, using their existing NGS instruments. As a result, patients will have better access to these vital tests and the significant benefits that they bring in personalizing breast cancer management.”

MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a binary low or high risk-of-cancer-recurrence result, while BluePrint analyzes 80 genes that classify a patient’s breast cancer into functional molecular subtypes. The new device, which combines both MammaPrint and BluePrint, can aid physicians in personalizing treatment management decisions for their patients by identifying women with early-stage breast cancer who are at a genomic low or high risk for distant metastasis within 5 years.

The MammaPrint BluePrint kit is an RNA-sequencing-based version of Agendia’s existing MammaPrint and BluePrint tests, which are currently performed centrally at the company’s laboratories in Irvine, Calif, and Amsterdam, the Netherlands. The kit was developed in partnership with Agilent Technologies, Santa Clara, Calif, using its SureSelect target enrichment system, and with Bluebee, Rijswijk, the Netherlands, which provided the secure and convenient data processing solution for clinicians.

For more information, visit Agendia.