Agendia's MammaPrint® breast cancer prognosis test is said to be the world's first In Vitro Diagnostic Multivariate Index Assay (IVDMIA) to acquire market clearance from the U.S. Food and Drug Administration (FDA).
Clearance of Agendia's ‘de novo 510K' application for MammaPrint® provides the legal basis for offering this service in the United States. Agendia had previously received clearance from European authorities to market MammaPrint® in Europe and substantial progress has already been made there in market acceptance and reimbursement.
Dr. Bernhard Sixt, Chief Executive Officer at Agendia notes: "The FDA's focus on the emerging field of molecular diagnostics underscores the growing importance of personalized medicine. Agendia is very pleased that its MammaPrint®, as the frontrunner in this area, is the first to receive clearance by the FDA. This is not only an acknowledgement of Agendia's efforts to provide state of the art technology for the benefit of cancer patients, but also sends a clear message to the medical community that our MammaPrint® test is reliable and clinically useful.
In Europe Agendia's service has already demonstrated its technical robustness and reliability, adding significant clinical value for physicians and breast cancer patients. We are exploring ways to make this product available in the US. We are also confident that the present FDA clearance of MammaPrint® will help to increase acceptance of this type of technology in clinical decision making for cancer in Europe".