Agendia, Irvine, Calif, a molecular cancer diagnostics company, announced that it has been granted the International Organization for Standardization (ISO) 13485 certification for all activities at their facilities in Irvine and Amsterdam. Agendia has compliance with FDA GMP QSR, CLIA, CAP, OSHA and the CE Mark as well as requirements for all 50 states in the US.
Agendia’s breast cancer Symphony suite consists of FFPE tissue tests that provide genomic information to support complex breast cancer treatment decisions. Agendia’s breast cancer Symphony™ suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint, a molecular subtyping assay, TargetPrint®, an ER/PR/HER2 expression assay, and TheraPrint®, an alternative therapy selection assay. Together, these tests help physicians determine a patient’s individual risk for metastasis and which patients will benefit from chemo, hormonal, or combination therapy.
