NEW YORK (GenomeWeb News) – Dutch molecular diagnostics firm Agendia has received Clinical Laboratory Improvement Amendments certification for its newly opened lab in Huntington Beach, Calif.
The firm has opened the lab to help drive US adoption of its MammaPrint breast cancer diagnostic test. Agendia received US Food and Drug Administration clearance of the array-based test two years ago and had been working with reference centers in the US to help drive sales. MammaPrint was the first IVDMIA microarray-based diagnostic test to be cleared by the FDA.
"Our enhanced domestic capabilities will help us to further drive adoption of MammaPrint, and place us in an even better position to collaborate with a growing number of clinical, academic, and industrial partners here in the US," Agendia President and CEO Bernhard Sixt said in a statement.
Agendia also operates a CLIA-certified lab in its home base of Amsterdam.