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Alternative Name
therascreen® FGFR RGQ RT-PCR Kit
Methodology
Molecular
Test Description

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).

For FGFR2 testing in cholangiocarcinoma, please see FGFR2 Rearrangement FISH.

Clinical Significance

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.

Specimen 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). 
Storage and Transportation

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

CPT Code(s)*
Prior to 12/31/2019 CPT Code 81479x1; as of 01/01/2020 CPT Code 0154U
Turnaround Time

8 business days / 10 calendar days

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
New York Approved
Yes
Level of Service
Global

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.