Vysis PathVysion HER-2 Kit Labeling: Herceptin Exclusion Endorsed By Panel
This article was originally published in The Gray Sheet
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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Vysis plans to submit a premarket approval application supplement to the Center for Devices and Radiological Health to add Genentech's Herceptin (trastuzumab) chemotherapy agent to the labeling of the PathVysion HER-2/neu gene amplification assay.
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