Genentech Herceptin
This article was originally published in The Gray Sheet
Executive Summary
Dako's HercepTest and Abbott/Vysis' PathVysion are the only tests currently approved by FDA for inclusion on labeling for the cancer therapy drug, Abbott notes. "The Gray Sheet" (Sept. 2, p. 18) incorrectly reported that Ventana Medical Systems' Pathway also was included. While the Ventana test was approved in 2000 via PMA for assessing Herceptin-treated patients, the test has not yet been added to Genentech's labeling...