FGFR3 Mutation Analysis with Interpretation
Label Mnemonic: FGFR3
Epic code: LAB8076
Order form: Molecular Oncology Requisition
Supply order: Supply Order Form
Billing: Billing Policies
CPT code: 81403
Specimen(s):
Voided Urine, Bladder Wash, Upper Urinary Tract Washings
(prepared by cytology from; urinary tract specimens)
Formalin fixed, paraffin embedded tissue block and 10 unstained 5-10 μM slides at 20-25°C and an H&E slide of the tissue
Collection Medium:
Sterile container
Minimum:
Urinary tract cytology specimens.

FFPE - Tumor cells more than 50% of the total tissue and greater than 10mm2 in surface area on the block.
Rejection Criteria:
FFPE specimens fixed in B5 fixative or that have been decalcified will not be accepted.

Squamous cell contamination greater than 90% of the total cells is unacceptable. At least 10% or greater of the total should be urothelial cells.

Direct 24 hour urine specimens. These specimens must be processed by cytology.
Testing Schedule:
Weekly
Turn Around Time:
Allow 7-10 days for final results.
Reference Range:
Negative
Comments:
FGFR3 testing should be performed in conjunction with cytological, histological evaluation. The FFPE tissue will be reviewed by a pathologist prior to testing to identify that it contains sufficient numbers of urothelial cells.

This assay detects mutations in FGFR3 Exons; 7, 9, 14.
Methodology:
Polymerase Chain Reaction and Single Nucleotide Primer Extension
Instructions:
Label the tube with patient name and medical record number.
Sample Processing:
Do Not Centrifuge.
Sample Storage:
Refrigerate.
Transport Instructions:
DO NOT FREEZE, protect specimen by wrapping in bubble-wrap or toweling.
CPT Code:
81403