Days Set Up
Monday - Thursday
Analytic Time

5-12 days

MiChart Code
Soft Order Code

Test Updated:


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Test Overview

Test Methodology

Next-Generation Sequencing

Test Usage

Fibroblast growth factor receptors (FGFR) are tyrosine kinases involved in the transduction of growth factor signaling. Mutations and translocations affecting the genes that encode these proteins (primarily FGFR2 and FGFR3) occur in approximately 20% of urothelial carcinomas, as well as in many other types of cancer. These mutations and translocations result in constitutive activation of the receptor and downstream growth signaling. Amplification of FGFR genes is also well-described in urothelial carcinoma.

The detection of these mutations and translocations can have important treatment implications. Erdafitinib (Balversa) is an FGFR-inhibitor that is FDA-approved for the treatment of metastatic urothelial cancers harboring susceptible mutations or translocations involving FGFR2 or FGFR3. Other FGFR-targeted therapies are being investigated in clinical trials for the treatment of urothelial carcinoma and other cancers with FGFR alterations.

This DNA and RNA based test is performed by targeted next-generation sequencing and will detect mutations within the sequenced regions of FGFR2 (NM_000141.4; exons 7, 8, 9, 12 and 14) and FGFR3 (NM_000142.4; exons 7, 9, 14 and 16). Commonly mutated codons within FGFR3 that are covered by this assay include R248, S249, G370 and Y373. In addition, this test will detect activating FGFR2 and FGFR3 gene fusions including FGFR3-TACC3, FGFR3-BAIAP2L1, FGFR2-BICC1 and FGFR2-CASP7. A complete list of sequenced regions and detectable fusion transcripts is available below.

Reference Range

Interpretive report provided.

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Specimen Requirements

Collection Offsite

For formalin-fixed, paraffin-embedded tissue, a block containing an area with a high percentage of neoplastic cells (for micro-/macro-dissection) is preferred. Unstained, UNBAKED slides (5-8, 10-micron slides; 10-15 if few neoplastic cells are present) with associated H&E stained slide are also acceptable. Decalcified tissue or other fixatives will be accepted and the assay attempted, however these may result in failed testing due to degraded nucleic acid. Both blocks and slides should be stored at room temperature. A Diff-Quik or Papanicolaou stained aspirate smear (preferable containing a high percentage and overall amount of neoplastic cells) is also acceptable. Store at room temperature.

Normal Volume
Formalin-fixed, paraffin-embedded tissue; Diff-Quik stained aspirate smear, Papanicolaou stained aspirate smear.Extracted DNA is also acceptable if extracted in a CLIA certified laboratory.
Minimum Volume

Billing Information

CPT Code
81404, 88381-TC
Pro Fee Code

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Our High Standard

Quality that sets us apart

As the reference laboratory division of Michigan Medicine's Department of Pathology, MLabs shares the institution's commitment to applying established quality principles to clinical laboratory testing. Like other large organizations in complex, consequential fields, we rely on an established approach to monitor quality throughout the testing process.