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Agendia Gets FDA Clearance for MammaPrint on Agilent Systems

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Agendia has received another clearance for the firm's MammaPrint breast cancer recurrence assay.

The new clearance is for running the test on two additional Agilent microarray scanners and two Agilent Bioanalyzers. Agendia said the additional clearance will expand laboratory capacity to handle the increasing number of MammaPrint, TargetPrint, and BluePrint test results.

Previously, the MammaPrint test was only allowed to be performed at Agendia's lab in Irvine, Calif. The new clearance enables the test to be run in a central laboratory and allows Agendia to also perform the test at its lab in Amsterdam, where the firm is based.

MammaPrint was the first in vitro diagnostic multivariate index assay device approved by the FDA in early 2007.