Agendia gets ISO accreditation for breast cancer risk assessment test
Agendia, a specialist in gene expression analysis-based diagnostics, has been granted ISO 17025 accreditation for its MammaPrint service, carried out at the company's laboratory facilities in Amsterdam, The Netherlands.
Agendia, a specialist in gene expression analysis-based diagnostics, has been granted ISO 17025 accreditation for its MammaPrint service, carried out at the company's laboratory facilities in Amsterdam, The Netherlands.
MammaPrint is a gene expression service that assesses the risk of metastasis (cancerous spread) in breast cancer patients. Agendia is the first company worldwide to be granted ISO accreditation for a microarray-based diagnostic test.
The accreditation is granted for four years, however the Dutch Accreditation Council will perform yearly inspections of the laboratory facilities.
MammaPrint gene expression service uses a 70-gene profile to classify breast cancer patients as 'low' or 'high' risk of developing distant metastasis in a 10-year period. It offers valuable information to oncologists and patients concerning the subsequent treatment plan for those at risk of developing metastasis.
Several studies in Europe and the US have demonstrated that MammaPrint outperforms conventional classifying methods such as the widely used St Gallen criteria.