Test Id : TLPDF

This test includes a charge for the probe application, analysis, and professional interpretation of results for 3 probe sets (6 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed.

When this test and flow cytometry testing for leukemia/lymphoma are ordered concurrently, the flow cytometry result will be utilized to determine if sufficient clonal T-cells are available for FISH testing. If the result does not identify a sufficient clonal T-cell population, this FISH test order will be canceled, and no charges will be incurred.

If FISH testing proceeds, all probes in the initial panel will be performed. The initial panel includes testing for the following abnormalities using the probes listed:

14q32.1 rearrangement, TCL1A break-apart

14q11.2 rearrangement, TRAD break-apart**

i(7q), D7Z1/D7S486

+8, D8Z2/MYC

**When a TCL1A rearrangement is not identified and the patient has T-cell prolymphocytic leukemia/lymphoma (T-PLL), reflex testing using the TRAD break-apart probe set will be performed.

See Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm, see in Special Instructions.

This test is intended for instances when a non-specific T-cell lymphoma fluorescence in situ hybridization (FISH) panel is needed.

If limited T-cell lymphoma FISH probes are preferred, order TLPMF / T-Cell Lymphoma, Specified FISH, Varies.

This test should only be ordered if the sample is known to have a sufficient clonal T-cell population. If a flow cytometry result is available and does not identify a sufficient clonal T-cell population, this test will be canceled, and no charges will be incurred.

For testing paraffin-embedded tissue samples from patients with T-lymphoblastic lymphoma (T-BLB), see TLBLF / T-Lymphoblastic Leukemia/Lymphoma, FISH, Tissue.

For patients with T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL), order either TALAF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies. or TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (T-ALL/LBL), FISH, Pediatric, Varies depending on the age of the patient.

Advise Express Mail or equivalent if not on courier service.

A reason for testing and a flow cytometry and/or a bone marrow pathology report should be submitted with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed. If this information is not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

Submit only 1 of the following specimens:

Preferred

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (heparin) or lavender top (EDTA)

Specimen Volume: 2-3 mL

Collection Instructions:

1. It is preferable to send the first aspirate from the bone marrow collection.

2. Invert several times to mix bone marrow.

Acceptable

Specimen Type: Blood

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (heparin) or lavender top (EDTA)

Specimen Volume: 6 mL

Collection Instructions: Invert several times to mix blood.

• Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm

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

Blood: 2 mL

Bone Marrow: 1 mL

Detecting a neoplastic clone associated with the common chromosome abnormalities observed in patients with various T-cell lymphomas using a laboratory-designated probe set algorithm

Tracking known chromosome abnormalities and response to therapy in patients with T-cell lymphoma

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

This test includes a charge for the probe application, analysis, and professional interpretation of results for 3 probe sets (6 individual fluorescence in situ hybridization [FISH] probes). Additional charges will be incurred for all reflex or additional probe sets performed.

When this test and flow cytometry testing for leukemia/lymphoma are ordered concurrently, the flow cytometry result will be utilized to determine if sufficient clonal T-cells are available for FISH testing. If the result does not identify a sufficient clonal T-cell population, this FISH test order will be canceled, and no charges will be incurred.

If FISH testing proceeds, all probes in the initial panel will be performed. The initial panel includes testing for the following abnormalities using the probes listed:

14q32.1 rearrangement, TCL1A break-apart

14q11.2 rearrangement, TRAD break-apart**

i(7q), D7Z1/D7S486

+8, D8Z2/MYC

**When a TCL1A rearrangement is not identified and the patient has T-cell prolymphocytic leukemia/lymphoma (T-PLL), reflex testing using the TRAD break-apart probe set will be performed.

See Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm, see in Special Instructions.

T-cell neoplasms are relatively uncommon, accounting for approximately 12% of all non-Hodgkin lymphomas. There are several subtypes of T-cell neoplasms: T-lymphoblastic leukemia (T-ALL), T-cell prolymphocytic leukemia (T-PLL), T-cell large granular lymphocytic leukemia (T-LGL), anaplastic large cell lymphoma (ALCL), peripheral T-cell lymphoma, and various other cutaneous, nodal, and extranodal lymphoma subtypes.

There are a few common chromosome abnormalities associated with specific T-cell lymphoma subtypes evaluated by this fluorescence in situ hybridization (FISH) test, as seen in the following table.

Table. Common Chromosome Abnormalities in T-cell Lymphomas

These probes have diagnostic relevance and can also be used to track response to therapy.

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 supports a diagnosis of a T-cell lymphoma. The specific abnormality detected may help subtype the neoplasm.

The absence of an abnormal clone does not rule out the presence of lymphoma.

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.

Bone marrow is the preferred sample type for this fluorescence in situ hybridization test. If bone marrow is not available, a blood specimen may be used if there are neoplastic cells in the blood specimen (as verified by a hematopathologist).

Each probe was independently tested and verified on unstimulated peripheral blood and bone marrow specimens. Normal cutoffs were calculated based on the results of 25 normal specimens. Each probe set was evaluated to confirm the probe set detected the abnormality it was designed to detect.

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

2. Gesk S, Martin-Subero JI, Harder L, et al: Molecular cytogenetic detection of chromosomal breakpoints in T-cell receptor gene loci. Leukemia. 2003;17:738-745. doi: 10.1038/sj.leu.2402884

3. Chin M, Mugishima H, Takamura M, et al: Hemophagocytic syndrome and hepatosplenic (gamma)(delta) T-cell lymphoma with isochromosome 7q and 8 trisomy. J Pediatr Hematol Oncol. 2004;26(6):375-378. doi: 10.1097/00043426-200406000-00008

This test is performed using commercially available and laboratory-developed probes. Rearrangements involving TCL1A and TRAD are detected using a dual-color break-apart strategy probe. Trisomy of chromosome 8 and isochromosome 7q are detected using enumeration strategy probes. For each probe set, 100 interphase nuclei are scored. All results are expressed as the percent abnormal nuclei.(Unpublished Mayo method)

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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.

88271 x6, 88275 x3, 88291 x1- FISH Probe, Analysis, Interpretation; 3 probe set

88271 x2, 88275 x1 - FISH Probe, Analysis; each additional probe set (if appropriate)