Original from: Agendia
Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia¡¯s strict adherence to rigorous quality and safety standards and ensures the tests¡¯ reliability and effectiveness in clinical settings across the EU.
¡°We are very proud to receive the IVDR certification for our MammaPrint and BluePrint tests and look forward to continuing our efforts in providing accurate and effective test results to those undergoing breast cancer treatment,¡± said Mark R. Straley, Chief Executive Officer of Agendia. ¡°This achievement not only underscores our commitment to delivering the highest standard of care to patients, but also highlights our ability to meet the stringent regulatory requirements necessary to address the needs of breast cancer patients and clinicians around the world.¡±
The IVDR certification marks a significant advancement in Agendia¡¯s efforts to enhance the decision- making around treatment pathways for those with early breast cancer.
