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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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