NEW YORK, Nov. 1 (GenomeWeb News) - Agendia has registered its MammaPrint microarray test as a medical device with the Dutch Healthcare Inspectorate, the company said today. Both the microarray and the array production were registered.
Agendia said the registration complies with Dutch law on medical devices and enables MammaPrint to bear the CE mark. Agendia recently received accreditation for MammaPrint.
The MammaPrint gene-expression service assesses the risk of metastasis in breast cancer patients with a 70-gene profile.
The Amsterdam, Netherlands-based company will also register its other genetic profile-based tests, such as CupPrint, a test for cancer of unknown primary patients.