Solid Tumors

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

References

  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

disease state indication(s)
Bladder Cancer

clinical use
FGFR CDx Molecular Analysis is a qualitative RT-PCR assay, FDA-approved for detection of four point mutations in the FGFR3 gene (p.R248C, p.S249C, p.G370C and p.Y373C) and two FGFR3 fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) to identify certain urothelial carcinoma patients for treatment with BALVERSA™ (erdafitinib).

The test also detects and reports an additional FGFR3 fusion (FGFR3:BAIAP2L1) and two FGFR2 fusions (FGFR2:BICC1 and FGFR2:CASP7).

methodology/product platform
Polymerase chain reaction (PCR)

specimen type and requirements
FFPE tissue: Paraffin block preferred. Please use 10% buffered formalin fixative. Do not use zinc fixatives. Required tissue is minimum 100mm2. Required Tumor content is 80%. (This is higher than most molecular tests and the amount of tumor required is more than one typically sees in core needle biopsy specimens).

Use cold pack for transport, making sure cold pack is not in direct contact with specimen.

turnaround time
8 business days / 10 calendar days

cpt code(s)
81479x1

medicare moldx cpt code
Not applicable

regulatory classification
FDA approved

ordering option
Global (TC & PC)