Test Id : SLL

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 probes performed. No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.

This test may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question, including the standard small lymphocytic lymphoma (SLL) FISH panel and the individual SLL FISH probes (per client request).

If the patient is being evaluated for known abnormalities, targeted probes must be listed in the probe request field. If no specific panel or FISH probes are indicated, the standard panel will be performed.

The standard SLL FISH panel includes testing for the following abnormalities, using the FISH probes listed:

6q-, D6Z1/MYB

11q-, D11Z1/ATM

+12, D12Z3/MDM2

13q-, D13S319/LAMP1

17p-, TP53/D17Z1

t(11;14), CCND1::IGH

When 3 IGH signals are identified suggesting an IGH rearrangement and no fusion with CCND1 is observed, additional testing with the t(14;19)(q32;q13) IGH::BCL3 FISH probe will be performed.

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.

This test does not include a pathology consultation. If a pathology consultation is requested, order PATHC / Pathology Consultation and the appropriate fluorescence in situ hybridization test (FISH) test will be added and performed at an additional charge.

Mayo Hematopathology Consultants are involved in both the preanalytic (tissue adequacy and probe selection, when applicable) and postanalytic (interpretation of FISH results in context of specific case, when applicable) phases.

This test is not appropriate for testing blood and bone marrow from patients with chronic lymphocytic leukemia. See CLLDF / Chronic Lymphocytic Leukemia (CLL), Diagnostic FISH, Varies or CLLMF / Chronic Lymphocytic Leukemia (CLL), Specified FISH, Varies.

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.

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. 

Acceptable 

Specimen Type: Tissue slides

Slides:1 Hematoxylin and eosin-stained (H and E) stained and 10 unstained 

Collection Instructions: Submit 1 slide stained with H and E and 10 consecutive, unstained, positively charged, unbaked slides with 5-micron-thick sections of the tumor tissue.

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

Slides: 1 Hematoxylin and eosin-stained and 6 unstained 

Recurrent common chromosome abnormalities in patients with small lymphocytic lymphoma (SLL)

Distinguishing patients with 11;14 translocations who have mantle cell lymphoma (MCL) from patients who have SLL

Detecting patients with atypical SLL or other forms of B-cell lymphoma associated with translocations between IGH and BCL3

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 probes performed. No analysis charges will be incurred if an insufficient number of representative cells are available for analysis.

This test may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question, including the standard small lymphocytic lymphoma (SLL) FISH panel and the individual SLL FISH probes (per client request).

If the patient is being evaluated for known abnormalities, targeted probes must be listed in the probe request field. If no specific panel or FISH probes are indicated, the standard panel will be performed.

The standard SLL FISH panel includes testing for the following abnormalities, using the FISH probes listed:

6q-, D6Z1/MYB

11q-, D11Z1/ATM

+12, D12Z3/MDM2

13q-, D13S319/LAMP1

17p-, TP53/D17Z1

t(11;14), CCND1::IGH

When 3 IGH signals are identified suggesting an IGH rearrangement and no fusion with CCND1 is observed, additional testing with the t(14;19)(q32;q13) IGH::BCL3 FISH probe will be performed.

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.

Small lymphocytic lymphoma (SLL) is the nonleukemic form of chronic lymphocytic leukemia (CLL), one of the most common leukemias in adults. The most frequently seen cytogenetic abnormalities in SLL involve chromosomes 6, 11, 12, 13 and 17. These are detected and quantified using the SLL fluorescence in situ hybridization (FISH) panel.

Cytogenetics has proven to be a reliable predictor of outcome for patients with CLL. It is unknown if SLL has the same prognostic significance when these genetic abnormalities are observed.

This FISH test detects an abnormal clone in approximately 65% of patients with SLL. Patients with t(11;14)(q13;q32) associated with CCND1::IGH fusion, have mantle cell lymphoma which can be distinguished from SLL and other B-cell lymphomas with this assay. Patients with t(14;19)(q32;q13.3) associated with IGH::BCL3 fusion, may have an atypical form of SLL or another B-cell lymphoma.

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 set.

A positive result is not diagnostic for small lymphocytic lymphoma but may provide relevant prognostic information.

The absence of an abnormal clone does not rule out the presence of an SLL clone or another neoplastic disorder.

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's) may not be successful for fluorescence in situ hybridization (FISH) assays. Non-formalin fixed samples 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%, but FISH will be attempted if sufficient tumor is present for analysis.

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 eds. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC; 2017. WHO Classification of Tumours, Vol 2

2. Shanafelt TD. Predicting clinical outcome in CLL: how and why. Hematology Am Soc Hematol Educ Program. 2009;421-429

3. Van Dyke DL, Werner L, Rassenti LZ, et al. The Dohner fluorescence in situ hybridization prognostic classification of chronic lymphocytic leukaemia (CLL): the CLL Research Consortium experience. Br J Haematol. 2016;173(1):105-113

This test is performed using commercially available and laboratory-developed probes. Deletion of chromosomes 6q, 11q, 13q, and 17p, and trisomy of chromosome 12 are detected using enumeration strategy probes. A dual-color, dual-fusion (D-FISH) strategy probe set is used to detect CCND1::IGH rearrangements and, for reflex testing, to identify IGH::BCL3 rearrangements. 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 engraving tool on the back of the unstained slide to be assayed. For each probe set, the probes are hybridized to the appropriate target areas and 2 technologists each analyze 50 interphase nuclei (100 total). All results are expressed as the percent abnormal nuclei.(Unpublished Mayo method)

Monday through Friday

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• 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