Agendia, a molecular cancer diagnostics company, has received the clinical laboratory permit from the New York State Department of Health. The permit allows Agendia to receive commercial samples of MammaPrint, its FDA-cleared breast cancer recurrence test.
With this Agendia has obtained all major US clinical laboratory licenses with this permit. In addition, the College of American Pathologists (CAP) has accredited Agendia’s CLIA regulated laboratory in Huntington Beach, CA.
Bernhard Sixt, chief executive officer of Agendia, said: “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.
“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 a breast cancer recurrence test cleared by the US Food and Drug Administration (FDA).