Agendia Receives New York State Laboratory Permit and Laboratory Accreditation by College of American Pathologists

By Agendia B.v., PRNE
Monday, February 8, 2010

HUNTINGTON BEACH, California and AMSTERDAM, February 9 - Agendia, a world leader in molecular cancer diagnostics, announced today
that it has received the Clinical Laboratory Permit from the New York State
Department of Health. The New York State permit allows the company to receive
commercial samples of MammaPrint, its FDA-cleared breast cancer recurrence

With this latest permit, Agendia has now obtained all major U.S. clinical
laboratory licenses. In addition, the College of American Pathologists (CAP)
has accredited Agendia's CLIA regulated laboratory in Huntington Beach, CA.

"The New York State permit is often recognized as one of the most
difficult to obtain. Together with our CAP accreditation, CLIA compliance,
and FDA-clearance for MammaPrint, we give patients and physicians the
confidence they need while making important treatment decisions," said Dr.
Bernhard Sixt, Agendia's Chief Executive Officer. "The growing clinical
importance of complex genomic testing means that our laboratories need to
meet the highest standards of quality for patients and health care

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 CAP-accredited and CLIA
compliant service laboratories. 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; Valerie Delva, Account Executive, Ricochet Public Relations, +1-212-679-3300 x131 Office, vdelva at

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