Agendia, a world leader in personalized medicine and molecular cancer diagnostics, and University Hospitals Leuven (UZ Leuven) in Belgium have partnered to co-validate Agendia’s new in vitro diagnostic (IVD) MammaPrint® BluePrint® Breast Cancer Risk of Recurrence and Molecular Subtyping Kit.
The study is a key step in preparation for CE-marking and European launch of the kit in early 2018.
In June 2017, Agendia announced an extension of its relationship with Agilent Technologies Inc. to develop an RNA sequencing-based version of its existing microarray-based MammaPrint and BluePrint tests.
Adding the MammaPrint BluePrint Kit to Agendia’s portfolio will enable cancer centers to run the tests on their existing next-generation sequencing (NGS) instruments in their own laboratories. Performing the test locally offers greater access so that more patients can benefit from the personalized treatment that these tests enable.
The study will involve UZ Leuven processing breast tumor samples from patients enrolled in the study using the NGS-based MammaPrint BluePrint Kit. Their results will be directly compared with those from the currently marketed MammaPrint microarray-based test, performed at the Company’s Amsterdam CLIA-certified and CAP-accredited laboratory, to demonstrate the comparability of the two technologies.
Dr. Marjolaine Baldo, Commercial Vice President, EMEA at Agendia, said: “UZ Leuven is one of the largest and most prestigious academic centers in Belgium and we are very pleased to have such a well-respected partner working alongside us to co-validate the performance of our decentralized kit. This is an exciting time for Agendia as co-validation is one of the final steps to complete before we launch our CE-marked MammaPrint BluePrint Kit in 2018. We look forward to providing both centralized and decentralized services, offering clinical labs, physicians and patients more choice in how they access these important tests.”
Prof. Dr. Giuseppe Floris, Breast Pathologist at UZ Leuven, said: “It is a real honor for us to be part of this technological advancement of the MammaPrint and BluePrint tests to NGS. This validation study is fully in-line with the molecular diagnostic strategies promoted by UZ Leuven in recent years. It has been great to see the enthusiastic acceptance of this project by all colleagues in genetics, medical oncology, oncologic surgery, gynecology, the multidisciplinary breast center and pathology, and this will be instrumental for the positive results of this endeavor. We at UZ Leuven are very excited for the possible implications of the success of this challenge, especially because eventually it will improve the treatment of our breast cancer patients.”
MammaPrint is an in vitro diagnostic test, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. MammaPrint is cleared by the US FDA and carries the CE Mark, enabling the use of the test in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. The test is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test that provide deeper insight leading to more clinically actionable breast cancer biology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.
Instinctif Partners (Agendia)
Ashley Tapp / Lynne Trowbridge / Samantha Cheung
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