Providing prognostic information and guiding treatment for patients with cholangiocarcinomas and other tumor types including bladder, thyroid, oral cavity, and brain
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 |
This test does not include a pathology consult. If a pathology consultation is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.
This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.
Fluorescence In Situ Hybridization (FISH)
Cholangiocarcinoma
This test does not include a pathology consult. If a pathology consultation is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.
This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.
Tissue
1. A pathology report is required in order for testing to be performed. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.
2. 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.
Question ID | Description | Answers |
---|---|---|
CG956 | Reason for Referral |
Submit only 1 of the following specimens:
Specimen Type: Tissue
Container/Tube: Formalin-fixed, paraffin-embedded tumor tissue block
Specimen Type: Slides
Specimen Volume: Four consecutive, unstained, 5-micron thick sections placed on positively charged slides and 1 hematoxylin and eosin-stained slide
If not ordering electronically, complete, print, and send an Oncology Test Request (T729) with the specimen
Two consecutive, unstained, 5- micron- thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Tissue | Ambient (preferred) | ||
Refrigerated |
Providing prognostic information and guiding treatment for patients with cholangiocarcinomas and other tumor types including bladder, thyroid, oral cavity, and brain
This test does not include a pathology consult. If a pathology consultation is requested, PATHC / Pathology Consultation should be ordered and the appropriate FISH test will be ordered and performed at an additional charge.
This test includes a charge for application of the first probe set (2 FISH probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.
Cholangiocarcinoma is a malignancy arising from the biliary tract epithelium. These tumors are often clinically advanced at the time of presentation and the prognosis is very poor with a short overall survival. Treatment is generally limited to surgical resection, which is associated with a high degree of morbidity, and palliative chemotherapy regimens. Therefore, additional treatment options are eagerly sought.
Rearrangement of the FGFR2 gene region has been identified in a subset of cholangiocarcinomas. These rearrangements result in overexpression of FGFR2, which offers the possibility of using targeted FGFR2-inhibitor therapy for treatment. FGFR2 rearrangement has been identified in a number of other cancers including those of the bladder, thyroid, oral cavity, and brain. In the future, it is likely that the presence of FGFR2 rearrangements will be exploited in the treatment of these cancers as well.
An interpretive report will be provided.
A positive result is detected when the percent of cells with an abnormality exceeds the normal cutoff for the probe set.
A positive result suggests rearrangement of the FGFR2 locus and a tumor that may be responsive to targeted FGFR2-inhibitor therapy.
A negative result suggests no rearrangement of the FGFR2 gene region at 10q26.1.
This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.
Fixatives other than formalin (eg, Prefer, Bouin) may not be successful for FISH assays; however, nonformalin fixed samples will not be rejected.
Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.
FISH analysis was performed on 38 paraffin-embedded tissue samples and 25 noncancerous lymph node control specimens. Rearrangement of FGFR2 was identified in 13 cholangiocarcinoma tumors. The normal controls were used to generate a normal cutoff for this assay.
1. Mitesh BJ, Champion MD, Egan JB, et al: Integrated Genomic Characterization Reveals Novel, Therapeutically Relevant Drug Targets in FGFR and EGFR Pathways in Sporadic Intrahepatic Cholangiocarcinoma. PLOS Genetics 2014 Feb;10(2):e1004135
2. Graham RP, Barr Fritcher EG, Pestova E, et al: Fibroblast growth factor receptor 2 translocations in intrahepatic cholangiocarcinoma. Hum Pathol 2014 Aug;45(8):1630-1638
3. Arai Y, Totoki Y, Hosoda F, et al: Fibroblast growth factor receptor 2 tyrosine kinase fusions define a unique molecular subtype of cholangiocarcinoma. Hepatology 2014;59:1427-1434
4. Wu YM, Su F, Kalyana-Sundaram S, et al: Identification of targetable FGFR gene fusions in diverse cancers. Cancer Discov June 2013;3(6):636-647
The test is performed using a laboratory-developed FGFR2 (10q26.1) dual-color break-apart strategy probe (BAP). Formalin-fixed, paraffin-embedded tissues 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 is performed by a pathologist. Using the H and E-stained slide as a reference, target areas are etched with a diamond-tipped etcher on the back of the unstained slide to be assayed. The probe set is hybridized to the appropriate target areas and 2 technologists each analyze 50 interphase nuclei (100 total) with the results expressed as the percent of abnormal nuclei.(Unpublished Mayo method)
Monday through Friday
This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
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)
88275 - Interphase in situ hybridization, 100 to 300 cells, each probe set (if appropriate)
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
FGFR2 | FGFR2 (10q26.1), FISH, Ts | 95784-5 |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
38094 | Result Summary | 50397-9 |
38095 | Interpretation | 69965-2 |
38096 | Result | 62356-1 |
38097 | Reason For Referral | 42349-1 |
38098 | Specimen | 31208-2 |
38099 | Source | 31208-2 |
38100 | Tissue ID | 80398-1 |
38101 | Method | 85069-3 |
38102 | Additional Information | 48767-8 |
38103 | Disclaimer | 62364-5 |
38104 | Released By | 18771-6 |