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Dako breast cancer diagnostic

This article was originally published in The Gray Sheet

Executive Summary

Danish cancer test maker gains FDA market go-ahead for its TOP2A FISH pharmDx test for assessing the risk of tumor recurrence and long-term survival in patients with high-risk breast cancer. Announced Jan. 14, the approval makes Dako the first to market a breast cancer test based on the TOP2A gene. Patients with normal TOP2A status have a better outcome than patients with TOP2A gene amplifications or deletions, so the TOP2A FISH (fluorescence in-situ hybridization) pharmDx "provides new prognostic information for additional groups of patients and may serve as an adjunct to existing HER2-testing," according to the company
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