Agendia has announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s MammaPrint(C) breast cancer diagnostic test. MammaPrint® is a gene expression profiling service to assess the risk of recurrence in breast cancer patients.

The US Food and Drug Administration has approved MammaPrint, a new genetic test that can help predict whether a woman’s early stage breast cancer is likely to come back after initial treatment. The MammaPrint® test uses advanced genetic technology to predict whether existing cancer will spread to other parts of a patient’s body (metastasize). The test relies on microarray analysis, a powerful tool for simultaneously studying the patterns of activity of large numbers of genes in biological specimens.

“Today’s FDA clearance of MammaPrint® is a milestone for patient care and safety,” said Dr. Bernhard Sixt, Chief Executive Officer at Agendia.

“As the first test of its kind cleared by the FDA, this type of regulatory review benefits breast cancer patients and provides regulatory clarity to the medical community. At present, MammaPrint® is the first cleared IVDMIA which can be marketed in the US in compliance with these new FDA guidelines. We are exploring ways to make this product available in the US,” Sixt continued.

“We are pleased about today’s FDA announcement as it signifies an important first step in standardizing IVDMIAs to ensure a safe and welcomed advancement in cancer diagnostics,” said Diane Blum, MSW, Executive Director of CancerCare.

Agendia is located in Amsterdam, the Netherlands.