Agendia has secured the CE-IVDR certification for its MammaPrint FFPE Microarray, BluePrint FFPE Microarray, and MammaPrint and BluePrint NGS Kit.
The certification is a requirement under the new European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) and is a pivotal step for Agendia in providing reliable and effective genomic assays for breast cancer treatment.
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The MammaPrint and BluePrint tests, which are already in use in the US and EU, allow clinicians to quickly identify the treatment plan, reduce the risk of both under- and over-treatment.
MammaPrint is a gene expression profiling test that assesses the risk of distant metastasis in early-stage breast cancer. It is the only FDA-cleared test, stratifying risk into four categories to aid in tailoring treatment plans.
BluePrint complements MammaPrint by providing molecular subtyping of the tumour, which can reveal aggressive Basal tumours that may require different treatment approaches.
It is designed to measure the activity of 80 key genes that are involved in the growth of a tumour to classify it as Luminal, Basal or HER2 types.
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By GlobalDataAgendia 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.”
