Agendia, BV (Amsterdam, The Netherlands), 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 [U.S. Centers for Medicare & Medicaid] 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.
MammaPrint is the first and only breast cancer-recurrence test cleared by the FDA. FDA clearance under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines requires clinical and analytic validation and reporting systems to ensure patient safety issues are addressed.
All MammaPrint tests are conducted in Agendia's Clinical Laboratory Improvement Amendments (CLIA)-accredited service laboratory. Breast cancer recurrence assays currently marketed by other manufacturers have not been subject to the rigorous FDA clearance process.
Building on a cutting-edge genomics platform for tumor gene expression profiling, the company's tests help physicians more accurately customize cancer treatments. Agendia markets four products, with several new genomic tests under development. In addition, Agendia collaborates with pharmaceutical companies to develop highly effective personalized drugs in the area of oncology.
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