TRACY GEORGE, MD - EXECUTIVE DIRECTOR OF CLINICAL TRIALS AND PHARMADX AT ARUP LABORATORIES - Preview 1
September 25, 1998 - trastuzumab, one of the first targeted therapies with a companion diagnostic, received #FDA approval in breast #cancer. The commercially available IHC and FISH companion #diagnostics were not incorporated into the pivotal clinical trial. They had to be subsequently "developed" and validated by way of concordance studies (which were not stellar). Does this still happen today? Have we begun to appreciate the importance of embedding companion diagnostics directly into clinical trials?