Test Id : TLYM

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 [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed. No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.

This FISH test allows different combinations of probes to be utilized based on the suspected lymphoma subtype, patient's age, and clinical question. The most appropriate probes to order are listed in the Common Chromosome Abnormalities in T-cell Lymphomas table in Clinical Information. Both the break apart TCL1A and TRAD FISH probes are performed concurrently and will not be performed in isolation. The TBL1XR1/TP63 FISH probe will only be performed, at the laboratory's discretion, to resolve or confirm TP63 rearrangement concerns.

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.

For information see Anaplastic Large Cell Lymphoma Evaluation Algorithm.

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.

Mayo Hematopathology Consultants are involved in both the pre-analytic (tissue adequacy and probe selection, when applicable) and post-analytic (interpretation of fluorescence in situ hybridization [FISH] results in context of specific case, when applicable) phases.

This assay detects chromosome abnormalities observed in paraffin-embedded tissue samples of patients with T-cell lymphoma. If a non-paraffin embedded bone marrow or blood sample is received for this test, the test will be canceled, and TLPMF / T-Cell Lymphoma, Specified FISH, Varies will be added and performed as the appropriate test.

For patients with B-cell lymphoma, order BLYM / B-Cell Lymphoma, FISH, Tissue.

Advise Express Mail or equivalent if not on courier service.

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.

4. A list of probes is required if select probes are necessary or if the patient is being tracked for known abnormalities. See Table in Clinical Information.

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 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. 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 2 unstained?for each probe set

Collection Instructions:

1. Include 1 hematoxylin and eosin-stained slide for the entire test order.

2. For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides

• Anaplastic Large Cell Lymphoma Evaluation Algorithm

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

See Specimen Required

Detecting common, recurrent chromosome abnormalities in various T-cell lymphomas in paraffin-embedded tissue specimens at diagnosis

Providing prognostic information in patients with documented systemic ALK-negative anaplastic large cell lymphoma

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 [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed. No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.

This FISH test allows different combinations of probes to be utilized based on the suspected lymphoma subtype, patient's age, and clinical question. The most appropriate probes to order are listed in the Common Chromosome Abnormalities in T-cell Lymphomas table in Clinical Information. Both the break apart TCL1A and TRAD FISH probes are performed concurrently and will not be performed in isolation. The TBL1XR1/TP63 FISH probe will only be performed, at the laboratory's discretion, to resolve or confirm TP63 rearrangement concerns.

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.

For information see Anaplastic Large Cell Lymphoma Evaluation Algorithm.

T-cell malignancies account for approximately 10% of all non-Hodgkin lymphomas and there are numerous subtypes with diagnostic and prognostic genetic abnormalities that can be evaluated by fluorescence in situ hybridization (FISH) testing. FISH is available for specific abnormalities in T-cell lymphoma subtypes; see Table.

Table. Common Chromosome Abnormalities in T-cell Lymphomas

An interpretive report will be provided.

A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.

Detection of an abnormal clone is supportive of a diagnosis of a T-cell lymphoma. The specific abnormality detected may help determine a T-cell lymphoma subtype and/or contribute to the prognosis.

The absence of an abnormal clone, or negative result, does not rule out the presence of a neoplastic disorder or change the pathologic diagnosis.

This test is not approved by the U.S. 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. 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 are observed post-hybridization, the case will be released indicating a lack of FISH results.

1. Swerdlow SH, Campo E, Harris NL, et al, eds. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. IARC Press; 2017. WHO Classification of Tumours. Vol 2.

2. Feldman AL, Law M, Remstein ED, et al. Recurrent translocations involving the IRF4 oncogene locus in peripheral T-cell lymphomas. Leukemia. 2009;23(3):574-580

3. Feldman AL, Dogan A, Smith Dl, et al. Discovery of recurrent t(6:7)(p25.3;q32.3) translocations in ALK-negative anaplastic large cell lymphomas by massively parallel genomics sequencing. Blood. 2011;117(3):915-919

4. Parilla Castellar ER, Jaffe ES, Said JW, et al. ALK-negative anaplastic large cell lymphoma is a genetically heterogeneous disease with widely disparate clinical outcomes. Blood. 2014;124(9):1473-1480

5. Vasmatzis G, Johnson SH, Knudson RA, et al. Genomics-wide analysis reveals recurrent structural abnormalities of TP63 and other p53-releated genes in peripheral T-cell lymphomas. Blood. 2012 Sep 13;120(11):2280-2289

This test is performed using commercially available and laboratory-developed probes. Rearrangements involving ALK, DUSP22-IRF4, TCL1A, TRAD, and TP63 are detected using a dual-color break-apart strategy probe. Trisomy of chromosome 8 and isochromosome 7q are detected using enumeration strategy probes. TP63::TBL1XR1 fusion is detected using a dual color, dual fusion probe set. The TBL1XR1/TP63 FISH probe set will only be performed when necessary to resolve or confirm TP63 rearrangement concerns.

Formalin-fixed, paraffin-embedded tissues are cut at 5 microns and mounted on positively charged glass slides. The selection of tissue and the 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 abnormal nuclei.(Unpublished Mayo method)

Monday through Friday

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• Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
• Prospective clients should contact their account representative. For assistance, contact Customer Service.

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.

88377 (if 1 probe set)

88377 x 2 (if 2 probe sets)

88377 x 3 (if 3 probe sets)

88377 x 4 (if 4 probe sets)

88377 x 5 (if 5 probe sets)

88377 x 6 (if 6 probe sets)

88377 x 7 (if 7 probe sets)

88377 x 8 (if 8 probe sets)