Abbott/Vysis PathVysion HER-2 Test Labeling Cleared To Carry Herceptin
This article was originally published in The Gray Sheet
Executive Summary
Vysis will file an amendment to its PathVysion PMA to include retrospective outcome data from Genentech comparing the fluorescence in situ hybridization (FISH) test with immunohistochemistry (IHC) in its product labeling
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