FGFR CDx Molecular Analysis is the first companion diagnostic test for identification of fibroblast growth factor receptor alterations in urothelial carcinoma. Patients with FGFR alterations identified by this test may be eligible for treatment with BALVERSA™ (erdafitinib) which is indicated for patients with locally advanced or metastatic urothelial carcinoma who have progressed on platinum-based chemotherapy.1

FGFR plays an important role in cell development, differentiation, survival, migration, angiogenesis and carcinogenesis2. FGFR aberrations can contribute to carcinogenic events by influencing PI3K/AKT, STAT and RAS/MAPK pathways3. FGFR3 abnormalities accounts for ~70% of non-muscle-invasive bladder cancers and 10-20% of invasive bladder cancers4. FGFR3 is considered as an important therapeutic target in both non-invasive and invasive UC5.

Alternative Name: therascreen® FGFR RGQ RT-PCR Kit


  1. FDA approves first targeted therapy for metastatic bladder cancer. Office Commissioner – https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-metastatic-bladder-cancer. Accessed May 9, 2019.
  2. Helsten T, Elkin S, Arthur E, Tomson BN, Carter J, Kurzrock R. The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next-Generation Sequencing. Clinical Cancer Research. 2015;22(1):259-267. doi:10.1158/1078-0432.ccr-14-3212.
  3. Costa R, Carneiro B, Taxter T, et.al. FGFR3-TACC3 fusion in solid tumors: mini review. Oncotarget. 2016;7(34):55924-55938. doi: 10.18632/oncotarget.10482.
  4. Chae YK, Ranganath K, Hemmerman P, et.al. Inhibition of the fibroblast growth factor receptor (FGFR) pathway: the current landscape and barriers to clinical application. Oncotarget. 2017;8(9):16052-16074. doi: 10.18632/oncotarget.14109.
  5. Williams S, Hurst C and Knowles M. Oncogenic FGFR3 gene fusions in bladder cancer. Human Molecular Genetics. 2013;22(4):795-803. doi:10.1093/hmg/dds486

The Bladder Cancer FISH test designed to detect aneuploidy for chromosomes 3, 7 and 17 and the 9p21 locus in urine specimens. This test is an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.