FDA Broadens Clearance for Agendia's MammaPrint(R)

By Agendia B.v., PRNE
Wednesday, December 16, 2009

HUNTINGTON BEACH, California and AMSTERDAM, December 17 - 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.

About MammaPrint(R)

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.

About Agendia

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.

Media Contacts: Hans Herklots, Head of Corporate Communications, Agendia, +31-20-462-1557 Office, +31-620-083-509 Mobile, hans.herklots at agendia.com; Valerie Delva, Account Executive, Ricochet Public Relations, +1-212-679-3300 x131 Office, vdelva at ricochetpr.com

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