NEW YORK — Agendia said Friday that its MammaPrint FFPE microarray, BluePrint FFPE microarray, and companion MammaPrint and BluePrint NGS kits — which are used to help in the treatment of breast cancer — have received In Vitro Diagnostic Medical Device Regulation (IVDR) certification from the European Union.
MammaPrint FFPE and BluePrint FFPE are versions of Agendia’s MammaPrint and BluePrint tests that use formalin-fixed paraffin-embedded tissue samples instead of fresh tissue to analyze the expression of specific genes in order to assess the risk of a breast tumor's spread and classify its type, respectively.
The IVDR came into force in mid-2022 and requires most molecular tests to be certified by a notified body, a designated standards organization.
The certification of the MammaPrint and BluePrint products "highlights our ability to meet the stringent regulatory requirements necessary to address the needs of breast cancer patients and clinicians around the world," Agendia CEO Mark Straley said in a statement.
Earlier this year, Irvine, California-based Agendia said the German Gynecological Oncology Working Group (AGO) included BluePrint in its list of predictive factors for neoadjuvant chemotherapy decision-making. AGO added MammaPrint to its list of prognostic and predictive factors for extended endocrine therapy the year before.