Vysis' PathVysion Could Join Dako Diagnostic On Herceptin Labeling
This article was originally published in The Gray Sheet
Executive Summary
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.