Agendia is pleased to announce that it has achieved certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three of its products: the MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and the MammaPrint® and BluePrint® NGS Kit. These products are classified as Class C under the IVDR, affirming Agendia’s adherence to stringent quality and safety standards and ensuring their reliability and effectiveness in clinical settings throughout the EU.
“This certification not only underscores our commitment to delivering the highest standards of care to patients but also highlights our capability to meet rigorous regulatory requirements, catering to the needs of breast cancer patients and healthcare professionals globally,” said Mark R. Straley, Chief Executive Officer of Agendia.
The IVDR certification marks a significant step forward in Agendia’s mission to enhance treatment decision-making for early-stage breast cancer patients. For more details about the MammaPrint and BluePrint tests and Agendia’s ongoing clinical trials, please visit: www.agendia.com.
About Agendia
Agendia is a leading innovator in precision oncology, specializing in early-stage breast cancer. The company provides reliable biological insights that support personalized treatment decisions for patients and their healthcare teams. Agendia’s advanced genomic assays, MammaPrint® and BluePrint®, enable clinicians to identify the most effective treatment plans, reducing the risk of under-treatment and over-treatment. Both assays are approved for clinical use in the US and EU.
Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California, and operates a state-of-the-art laboratory facility. With leadership from renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research, including the significant FLEX Study— the world’s largest real-world evidence-based breast cancer database, aiming to revolutionize precision in breast cancer management. Agendia is dedicated to shaping the future of precision oncology and making a substantial impact in the fight against breast cancer.
About MammaPrint
MammaPrint® is a gene expression profiling test that assesses the underlying biology of an early-stage tumor to determine its risk of metastasis. It is the only FDA-cleared test for evaluating a woman’s risk of distant metastasis. MammaPrint analyzes signals from 70 key genes in a tumor to categorize the risk into four distinct groups—UltraLow, Low, High 1, and High 2—helping to tailor the treatment plan to the patient’s biological profile and life goals.
About BluePrint
BluePrint® is a gene expression profiling test that identifies the driving forces behind a tumor’s growth at the earliest stage of breast cancer treatment, aiding in the optimization and personalization of treatment plans. As the sole molecular subtyping test available in the US, BluePrint provides critical insights that complement pathology and improves treatment outcomes. It measures the activity of 80 key genes involved in tumor growth to classify the tumor as Luminal-type, HER2-type, or Basal-type, each requiring specific treatment approaches. BluePrint helps identify aggressive Basal tumors that may be misclassified, ensuring patients receive the most appropriate treatment from the outset.
