Agendia, a world leader in molecular cancer diagnostics, announced today 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 for MammaPrint," said Dr.
Bernhard Sixt, Agendia's Chief Executive Officer.
"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," said Dr. Richard Bender, Chief
Medical Officer of Agendia. "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." In
Europe, MammaPrint has been approved for all ages since 2004.
SOURCE Agendia B.V.