FDA Broadens Clearance for MammaPrint

Agendia, a leader in molecular cancer diagnostics, recently announced that the US Food and Drug Administration (FDA) cleared its MammaPrint breast cancer recurrence test for all ages. MammaPrint is the only FDA-cleared breast cancer recurrence test available to patients and physicians. Over the past 3 years, the FDA has issued four clearances for MammaPrint, covering all aspects of this service.

“This FDA clearance, along with our recently obtained CMS coverage for all stage I and II breast cancer patients, including patients with up to three positive lymph nodes, will facilitate our discussions with health-care providers about patients’ eligibility criteria for MammaPrint,” said Dr. Bernhard Sixt, Agendia’s chief executive officer.