HUNTINGTON BEACH, California and AMSTERDAM, February 9 /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 s
|SOURCE Agendia B.V.|
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