Ventana develops test for Novartis' Gleevec:
This article was originally published in Clinica
Executive Summary
Ventana Medical Systems is developing a diagnostic kit designed for use with Novartis Pharmaceutical's drug Gleevec (imatinib), the first signal transduction inhibitor approved in the US. The FDA approved Gleevec in 2001 for use with chronic myeloid leukaemia patients and subsequently extended its labelling in February 2002 for treating patients with c-kit positive inoperable and/or metastatic malignant gastrointestinal stromal tumours. Ventana, of Tucson, Arizona, is collaborating with Novartis to develop a diagnostic kit for c-kit and to file a premarketing approval (PMA) application with the FDA for the test.