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Test Code TFEBF Renal Cell Carcinoma, 6p21.1 (TFEB) Rearrangement, FISH, Tissue


Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


Provide a pathology report with each tissue specimen. The laboratory will not reject a specimen that arrives without this information but will hold the specimen until a pathology report is received.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Tissue

Container/Tube: Formalin-fixed, paraffin-embedded tumor tissue block

 

Specimen Type: Slides

Specimen Volume: 4 Consecutive, unstained, 5 micron-thick sections placed on positively charged slides and 1 hematoxylin and eosin-stained slide


Forms

If not ordering electronically, complete, print, and send an Oncology Test Request Form (T729) with the specimen (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

Secondary ID

64973

Useful For

Identifying TFEB gene rearrangements in patients with renal cell carcinoma (RCC)

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
_I099 Interphases, 25-99 No, (Bill Only) No
_I300 Interphases, ≥100 No, (Bill Only) No
_IL25 Interphases, <25 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
_PBCT Probe, +2 No, (Bill Only) No

Testing Algorithm

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.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

TFEB, 6p21.1, FISH

Specimen Type

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
Tissue Ambient (preferred)
  Refrigerated 

Reject Due To

No specimen should be rejected.

Clinical Information

The TFEB gene may be altered in some patients with renal cell carcinoma (RCC). Identification of rearrangement of the TFEB gene region by FISH analysis can aid in the diagnosis of RCC.

Reference Values

An interpretive report will be provided.

Interpretation

A positive result with the TFEB probe is detected when the percent of cells with an abnormality exceeds the normal cutoff for the probe set. A positive result of TFEB suggests promotor substitution caused by structural alterations of the TFEB gene region at 6p21.1. A negative result suggests no structural alterations of the locus.

Clinical Reference

1. Argani P, Yonescu R, Morsberger L, et al: Molecular confirmation of t(6:11)(p21;q12) renal cell carcinoma in archival paraffin-embedded material using a break-apart TFEB FISH assay expands its clinicopathologic spectrum. Am J Surg Pathol 2012 Oct;36(10):1516-1526

2. Argani P, Cheville J, Ladanyi M: MiT family translocation renal cell carcinomas. In WHO Classifications of Tumours of Urinary System and Male Genital Organs. Fourth edition. Edited by H Moch, PA Humphrey, TM Ulbright, VE Reuter VE. Lyon, France, IARC Press, 2016, 33-34

Day(s) and Time(s) Performed

Samples processed Monday through Sunday. Results reported Monday through Friday, 8 a.m.-5 p.m.

Analytic Time

7 days

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

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 U.S. Food and Drug Administration.

CPT Code Information

88271 x 2, 88291-DNA probe, each (first probe set), Interpretation and report

88271 x 2-DNA probe, each; each additional probe set (if appropriate)

88271 x 1-DNA probe, each; coverage for sets containing 3 probes (if appropriate)

88271 x 2-DNA probe, each; coverage for sets containing 4 probes (if appropriate)

88271 x 3-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)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TFEBF TFEB, 6p21.1, FISH In Process

 

Result ID Test Result Name Result LOINC Value
92350 Result Summary 50397-9
92351 Interpretation In Process
92352 Result In Process
GC002 Reason for Referral 42349-1
92353 Specimen 31208-2
92354 Source In Process
92355 Tissue ID In Process
92356 Method 49549-9
92357 Additional Information In Process
92358 Disclaimer 62364-5
92359 Released By In Process