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."
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.
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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