- Available tissue that was obtained at or after the time the usbject was found to have muscle invasive disease and is of suitable quality and quantity and to assess the FGFR3 status by genetic testing. For subjects participating in the Randomized Phase only, if suitable archival tissue is unavailable, then a core biopsy of tumor tissue (metastatic or primary) must be obtained prior to randomization even if a blood sample sample was used to determine FGFR3 genetic status