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Test Code LABFGF1F FGFR1 (8p11.2) Amplification, FISH, Tissue

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic Mayo Test ID
FGFR1 (8P11.2) AMPLIFICATION, FISH, TISSUE LABFGF1F FGF1F FGF1F

 

Useful For

Providing prognostic information and guiding treatment primarily for patients with squamous cell carcinoma of the lung, breast, esophagus, thymus, and other locations

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, Ts

Specimen Type

Tissue


Ordering 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.

1. Patient name

2. Block number - must be on all blocks, slides, and paperwork

3. Date of collection

4. 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

Collection Instructions: Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

Additional Information:

1. Paraffin-embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc).

2. Bone specimens that have been decalcified will be attempted for testing, but the success rate is approximately 50%.

 

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

Two consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

Specimen Stability Information

Specimen Type Temperature Time Special Container
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 is associated with tumor growth. Studies have shown overexpression or amplification of FGFR1 to be sensitive to FGFR1-tyrosine kinase inhibitors, and FGFR1 inhibitors may be a promising therapeutic option. Therefore, patients with FGFR1 amplification may be candidates for FGFR1 tyrosine kinase inhibitor therapies.

Reference Values

An interpretive report will be provided.

Interpretation

FGFR1 will be clinically interpreted as positive or negative.

 

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 US Food and Drug Administration and is best used as an adjunct to existing clinical and pathologic information.

 

Fixatives other than formalin (eg, Prefer, Bouin's) may not be successful for fluorescence in situ hybridization (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%.

 

FISH studies will be attempted if sufficient tumor is present for analysis. If insufficient tissue/tumor is available for testing, the pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.

 

If no FISH signals are observed post-hybridization, the case will be released indicating a lack of FISH results.

Supportive Data

FISH analysis was performed on 40 paraffin-embedded tissue samples from patients with various tumors. A series of normal control samples were used to generate the normal cutoffs. FGFR1 amplification was detected in 2 of 40 (5%) of samples. Other abnormalities including aneusomy, duplication and deletion of FGFR1 were also identified and may be observed in addition to FGFR1 amplification in tumor samples.

Method Description

This test is performed using a commercially available FGFR1 probe set with a FGFR1 probe and a chromosome 8 centromere probe (D8Z2). 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 days

Specimen Retention Time

Slides and H and E used for analysis are retained by the laboratory in accordance with regulatory requirements. Client provided paraffin blocks and extra unstained slides will be returned after testing is complete.

Performing 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

Forms

If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen.