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Vysis PathVysion HER-2 Kit Labeling: Herceptin Exclusion Endorsed By Panel

This article was originally published in The Gray Sheet

Executive Summary

Labeling for Vysis' PathVysion HER-2 DNA probe kit should state that results from the test are intended for use as a rapid assessment of the potential response to Adriamycin therapy, FDA's Immunology Devices panel concluded at a Nov. 9 meeting.

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