Agendia Boasts Expanded Clearance, Reimbursement For Breast Cancer Test
This article was originally published in The Gray Sheet
Executive Summary
Gene expression test maker Agendia will ramp up its U.S. marketing efforts after gaining expanded FDA clearance and Medicare coverage for its flagship MammaPrint breast cancer recurrence test
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FDA Clears First-Of-A-Kind Breast Cancer Recurrence Test
Dutch firm Agendia's MammaPrint test for predicting breast cancer recurrence set regulatory precedent Feb. 6 when it received 510(k) clearance