Agendia of Amsterdam, the Netherlands, has received market clearance from the FDA for its MammaPrint breast cancer diagnostic test. The device performs DNA microarray-based laboratory tests that measure the expression of 70 genes to predict the likelihood that the cancer will spread to another site. Information gained from the in vitro diagnostic multivariate index assays may help physicians plan follow-up treatment. The company had already been granted clearance to market the product in Europe.
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