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Agendia B.V.

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

Huntington Beach, California and Amsterdam (ots/PRNewswire)
-- 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 test.
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 professionals."
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.

Contact:

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

Plus de actualités: Agendia B.V.
Plus de actualités: Agendia B.V.
  • 17.12.2009 – 14:19

    FDA Broadens Clearance for Agendia's MammaPrint(R)

    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 ...

  • 08.12.2009 – 14:37

    Agendia to Present Broad Array of Data at 2009 San Antonio Breast Cancer Symposium

    Huntington Beach, California and Amsterdam (ots/PRNewswire) -- Agendia, a world leader in molecular cancer diagnostics, announced today that it will be presenting six studies focusing on MammaPrint(R) at the 2009 San Antonio Breast Cancer Symposium (SABCS), one of the premiere conferences in breast cancer research worldwide. The SABCS will take place December ...