BioCentury
ARTICLE | Clinical News

Ventana HER2/neu regulatory update

January 6, 2014 8:00 AM UTC

Last month, Roche's Ventana Medical Systems Inc. unit said the label of its Ventana HER2/neu (4B5) Rabbit Monoclonal Primary Antibody assay was expanded outside the U.S. to Detect HER2 protein expression for patients who may be appropriate candidate for Kadcyla ado-trastuzumab emtansine ( T-DM1) and Perjeta pertuzumab from Roche and its Genentech Inc. unit. The fully automated and standardized immunohistochemistry (IHC) test is already approved for the identification of HER2-positive breast and gastric cancer patients for whom Roche's Herceptin trastuzumab treatment is being considered. ...