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Personalized Diagnostic Kit for Breast Cancer Patients Receives CE Mark

US-Dutch biotech Agendia has now received a CE Mark for its next-generation sequencing-based MammaPrint BluePrint breast cancer recurrence and molecular subtyping kit, allowing the firm to commercialize the device in Europe.

This 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 five years.

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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 which classify a patient’s breast cancer into functional molecular subtypes.

Agendia’s MammaPrint test has proven that it can prevent the unnecessary use of chemotherapy in 46% of breast cancer patients. The new test builds on this concept by adding an analysis of the molecular profile of the patient’s cancer that can help determine what’s the best alternative to chemo for each patient.

Dr. William Audeh, Chief Medical Officer at Agendia, said: “The clinical utility of the MammaPrint test has been demonstrated by the landmark MINDACT trial. With breast cancer being the most common cancer in women, affecting one in eight in Europe and with almost 500,000 new cases a year, the quality-of-life and cost benefits of identifying women previously selected for chemotherapy that may not have significant benefit from it is considerable.

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Dr. Marjolaine Baldo, Commercial Vice President, EMEA at Agendia said: “Obtaining the CE mark for the MammaPrint BluePrint Kit is a huge milestone. For the first time, prestigious cancer centers across 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. We are proud of the drive, dedication and expertise of our team, partners and co-validation centers who, in recognizing the need for a decentralized solution, have worked tirelessly to develop, validate and deliver this important device to the market.  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.

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