Breast Cancer
FDA Broadens Clearance for Agendia's MammaPrint(R)
Published in Women's Health Weekly, December 31st, 2009
Agendia, a world leader in molecular cancer diagnostics, 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 three years, the FDA has issued four clearances for MammaPrint, covering all aspects of this important 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 healthcare providers about patients' eligibility criteria...
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