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HelpTest Code FGF1F FGFR1 (8p11.2) Amplification, FISH, Tissue
Useful For
Identifying patients with squamous cell carcinoma of the lung, breast, esophagus, thymus, and other locations who may benefit from treatment with directed kinase inhibitors
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| _PBCT | Probe, +2 | No, (Bill Only) | No |
| _PADD | Probe, +1 | No, (Bill Only) | No |
| _PB02 | Probe, +2 | No, (Bill Only) | No |
| _PB03 | Probe, +3 | No, (Bill Only) | No |
| _IL25 | Interphases, <25 | No, (Bill Only) | No |
| _I099 | Interphases, 25-99 | No, (Bill Only) | No |
| _I300 | Interphases, >=100 | No, (Bill Only) | No |
Testing Algorithm
This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 individual fluorescence in situ hybridization probes). No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.
Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.
Method Name
Fluorescence In Situ Hybridization (FISH)
Reporting Name
FGFR1 (8p11.2) Amp, FISH, TsSpecimen Type
TissueOrdering Guidance
This test does not include a pathology consultation. If a pathology consultation is requested, order PATHC / Pathology Consultation, and appropriate testing will be added at the discretion of the pathologist and performed at an additional charge.
Multiple oncology (cancer) gene panels are also available. For more information see Hematology, Oncology, and Hereditary Test Selection Guide.
Shipping Instructions
Advise Express Mail or equivalent if not on courier service.
Necessary Information
1. A pathology report is required for testing to be performed. If not provided, appropriate testing and/or interpretation may be compromised or delayed. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.
2. The following information must be included in the report provided.
-Patient name
-Block number - must be on all blocks, slides, and paperwork
-Date of collection
-Tissue source
3. A reason for testing must be provided. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.
Specimen Required
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Tissue block (fresh tissue is not acceptable)
Collection Instructions:
1. Submit a formalin-fixed, paraffin-embedded tumor tissue block.
2. Blocks prepared with alternative fixation methods (eg, Prefer, Bouin’s) will be attempted but are less favorable for successful results. Provide fixation method used.
Additional Information:
1. Paraffin-embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc.).
2. Decalcified paraffin-embedded specimens will have testing attempted; however, the success rate is approximately 50%. Testing may be canceled if sufficient tumor tissue is not present.
3. Submitted fresh tissue specimens will be canceled upon receipt. If only fresh tissue is available, embed in paraffin prior to sending.
Acceptable:
Specimen Type: Tissue slides
Slides: 1 Hematoxylin and eosin-stained and 4 unstained
Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 4 consecutive unstained, positively charged, unbaked slides with 5 micron-thick sections of the tumor tissue.
Specimen Minimum Volume
Slides: 1 Hematoxylin and eosin stained and 2 unstained
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Tissue | Ambient (preferred) | |
| Refrigerated | ||
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Clinical Information
Fibroblast growth factor receptor 1 (FGFR1) is a receptor tyrosine kinase. FGFR1 overexpression or amplification in squamous cell carcinoma and other neoplastic processes and is associated with tumor growth. Studies have shown overexpression or amplification of FGFR1 to be sensitive to targeted kinase inhibitors, and FGFR1 inhibitors may be a promising therapeutic option. Therefore, patients with FGFR1 amplification may be candidates for kinase inhibitor therapies.
Reference Values
An interpretive report will be provided.
Interpretation
FGFR1 will be clinically interpreted as positive, negative, or equivocal.
The FGFR1 locus is reported as amplified (positive) when the FGFR1:D8Z2 ratio is greater than 2.0 or an average of 6 or more copies of the FGFR1 probe are observed per tumor nucleus.
A tumor with an FGFR1:D8Z2 ratio less than or equal to 2.0 and having an average of less than 6 copies of FGFR1 per tumor nucleus is considered negative for amplification of the FGFR1 locus.
A negative result does not exclude the presence of a neoplastic disorder.
Cautions
This test is not approved by the U.S. Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.
This fluorescence in situ hybridization (FISH) assay does not rule out other chromosome abnormalities.
Fixatives other than formalin (eg, Prefer, Bouin's) may not be successful for FISH assays. Non-formalin fixed specimens will not be rejected.
Paraffin-embedded tissues that have been decalcified may not be successful for FISH analysis. The success rate of FISH studies on decalcified tissue is approximately 50%, but FISH will be attempted if sufficient tumor is present for analysis.
FISH studies will be attempted if sufficient tumor is present for analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing if insufficient tissue/tumor is available for testing.
If no FISH signals or a lack of sufficient tumor tissue are observed post-hybridization, the case will be released indicating a lack of FISH results.
Method Description
This test is performed using a commercially available FGFR1 FISH probe and a chromosome 8 centromere probe (D8Z2). Paraffin-embedded tissue samples are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the identification of target areas on the hematoxylin and eosin (H and E)-stained slide are performed by a pathologist. Using the H and E-stained slide as a reference, target areas are etched with a diamond-tipped engraving tool on the back of the unstained slide to be assayed. The probe set is hybridized to the appropriate target areas, and 2 technologists each independently analyze 30 interphase nuclei (60 total) with the results expressed as a ratio of FGFR1:D8Z2 signals.(Unpublished Mayo method)
Day(s) Performed
Monday through Friday
Report Available
7 to 10 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88271x2, 88291-DNA probe, each (first probe set), Interpretation and report
88271x2-DNA probe, each; each additional probe set (if appropriate)
88271x1-DNA probe, each; coverage for sets containing 3 probes (if appropriate)
88271x2-DNA probe, each; coverage for sets containing 4 probes (if appropriate)
88271x3-DNA probe, each; coverage for sets containing 5 probes (if appropriate)
88274 w/modifier 52-Interphase in situ hybridization, <25 cells, each probe set (if appropriate)
88274-Interphase in situ hybridization, 25 to 99 cells, each probe set (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| FGF1F | FGFR1 (8p11.2) Amp, FISH, Ts | 78915-6 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 55213 | Result Summary | 50397-9 |
| 55214 | Interpretation | 69965-2 |
| 55216 | Result | 78915-6 |
| CG939 | Reason for Referral | 42349-1 |
| 55217 | Specimen | 31208-2 |
| 55218 | Source | 31208-2 |
| 55219 | Tissue ID | 80398-1 |
| 55220 | Method | 85069-3 |
| 55221 | Additional Information | 48767-8 |
| 55222 | Disclaimer | 62364-5 |
| 55225 | Released By | 18771-6 |