The FDA has cleared Agendia’s MammaPrint breast cancer recurrence test for all ages. MammaPrint is the FDA-cleared breast cancer recurrence test available to patients and physicians. Over the past three years, the FDA has issued four clearances for MammaPrint. In Europe, MammaPrint has been approved for all ages since 2004.
The company claims that MammaPrint identifies patients with early metastasis risk. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests.
Bernhard Sixt, CEO of Agendia, said: “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 for MammaPrint.”
Richard Bender, chief medical officer of Agendia, said: “This new clearance confirms the opinion of the international medical community that MammaPrint carries clinical utility and is safe and effective in breast cancer patients of all ages. Seeking clearance for all ages further demonstrates Agendia’s commitment to provide patients and physicians with high quality FDA-cleared tests to help guide vital treatment decisions.”