Huntington Beach, California and Amsterdam (ots/PRNewswire)
-- 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
"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
"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 U.S. Food and Drug Administration (FDA).FDA clearance
under the in vitro diagnostic multivariate index assay (IVDMIA)
guidelines requires clinical and analytical validation and reporting
systems to ensure patient safety issues are addressed. Highly
accurate, MammaPrint identifies patients with early metastasis risk -
patients who are likely to develop metastases within five years
following surgery. 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.
All MammaPrint tests are conducted in Agendia's CLIA-accredited
service laboratory. Breast cancer recurrence assays currently
marketed by other manufacturers have not been subject to the rigorous
FDA clearance process.
Agendia is at the forefront of the personalized medicine
revolution, striving to bring more effective, individualized
treatments within reach of patients. Building on a cutting-edge
genomics platform for tumor gene expression profiling, the company's
tests help physicians more accurately tailor 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. Agendia is based in Huntington Beach, California, and
in Amsterdam, The Netherlands.
ots Originaltext: Agendia B.V.
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Communications,Agendia, +31-20-462-1557 Office, +31-620-083-509
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