MammaPrint® Reimbursement Indication Extended in Belgium

Agendia®, Inc. announced today that the National Institute for Sickness and Invalidity Insurance (INAMI-RIZIV) located in Brussels has expanded the reimbursement indication for MammaPrint^® to include its use in the neoadjuvant setting, effective January 1, 2025. The genomic assay will now be available for full reimbursement for patients with HR+/HER2 negative early-stage breast cancer in both the pre- and postoperative settings, enabling testing on core needle biopsies for neoadjuvant treatment decisions—a pivotal advancement in providing patients with the personalized care they require.

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"The ability to now use MammaPrint on core needle biopsy specimen in Belgium represents a significant step for personalized treatment for women battling breast cancer," said Professor Martine Piccart, Honorary Professor of Oncology at the Université Libre de Bruxelles. "The benefits of neoadjuvant treatment are substantial, particularly when guided with MammaPrint. The test enables physicians to tailor treatment plans more precisely, which could enable less extensive surgical procedures with proper treatment selection."

MammaPrint has demonstrated robust performance in the neoadjuvant setting through, among others, the FLEX Study (NCT03053193) -- a prospective, real-world evidence, whole transcriptome, observational, breast cancer study. MammaPrint is a breast cancer genomic assay demonstrating a high level of concordance between matched surgical resection samples and core needle biopsy specimens. This recent indication extension to include both the pre- and postsurgical setting reflects the test’s clinical utility. The change in reimbursement policy underscores how critical genomic testing is in the management of a patient’s breast cancer.

“The expansion of the reimbursement indication of our genomic test, MammaPrint, is an exciting advancement in the battle against breast cancer", said Mark Straley, Chief Executive Officer at Agendia. "This expansion gives women with breast cancer broader access to Agendia's cutting-edge diagnostics that serve as the cornerstone for tailored treatment decisions. We appreciate INAMI-RIZIV's acknowledgement of the significance of precision medicine and eagerly anticipate our ongoing contribution to improving outcomes for breast cancer patients in Belgium."

About Agendia

Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint^® + BluePrint^®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment.

Agendia was founded in 2003 and is headquartered in Amsterdam with its state-of-the-art laboratory facility located in Irvine, CA. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study – the world’s largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer.

About MammaPrint

MammaPrint^® is a gene expression profiling test that reveals the distinct underlying biology of an early-stage tumor to determine its risk of spreading. As the only FDA-cleared gene expression profiling test to assess a woman’s risk of distant metastasis, MammaPrint^® provides critical answers that help inform the future of her treatment plan at the point of diagnosis, including the timing and benefit to chemotherapy and endocrine therapy. MammaPrint^® listens to the signals from 70 key genes in a woman’s tumor to stratify her risk within four distinct categories – ranging from UltraLow, Low, High 1, and High 2– to fuel a right-sized care plan tailored to her biology and her life’s plans.

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