Agendia has secured certification under the European Union’s (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for its MammaPrint FFPE Microarray and the BluePrint FFPE Microarray.
The California-based precision oncology firm has also received CE-IVDR certification for its MammaPrint and BluePrint NGS Kit.
These products are classified as Class C under this regulation.
According to Agendia, the certification ensures the reliability and effectiveness of these tests in clinical settings throughout the EU.
MammaPrint is a gene expression profiling test that analyses the genes in an early-stage tumour to determine its risk of spreading.
It is said to be the only US Food and Drug Administration (FDA)-cleared test for predicting distant metastasis, helping doctors decide on the best treatment plan, including the need and time for chemotherapy or endocrine therapy.
MammaPrint sorts the risk into four categories, which are UltraLow, Low, High 1, and High 2, based on 70 key genes.
BluePrint is designed to help identify the main characteristics of a tumour to guide treatment decisions during a woman’s breast cancer care journey.
It is claimed to be the only molecular subtyping test available in the US, offering insights that traditional pathology might miss.
By analysing 80 key genes, the assay classifies tumours into Luminal-type, HER2-type, or Basal-type, ensuring patients receive the most effective treatment.
Agendia CEO Mark Straley said: “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.
“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.”
Agendia specialises in early-stage breast cancer and provides valuable insights to help personalise treatment.
Founded in 2003 in Amsterdam, the precision oncology firm operates an advanced laboratory.
The company is advancing the FLEX Study, which is said to be the largest real-world breast cancer database designed to improve precision in breast cancer care.
