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NY State Grants Clinical Lab Permit to Agendia

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Amsterdam-based Agendia said today that New York regulators have granted the firm a clinical laboratory permit, enabling it to receive commercial samples for its MammaPrint breast cancer recurrence assay from NY state residents.

The company said that with the latest permit from the New York State Department of Health, it has all major US clinical laboratory licenses. The firm's MammaPrint test, which is a multivariate index assay, received marketing clearance from the US Food and Drug Administration three years ago.

Agendia also said that the College of American Pathologists has accredited the firm's lab in Huntington Beach, Calif.

"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," Agendia CEO Bernhard Sixt said in a statement, adding that the permit from New York is "recognized as the most difficult to obtain."