Test Id : JLYMF

This test is designed to detect the most common genomic changes in B-cell lymphoma including MYC-IGH fusion and rearrangement of MYC, BCL2, and BCL6 genes.

The oncologists and/or pathologists may order a single or all 4 fluorescence in situ hybridization (FISH) tests based on clinical needs. The lab will only perform the FISH tests that are ordered and report each separately within the same report. A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

Given the clinical importance of identifying the double-hit high grade B-cell lymphoma and the urgency of available results, one order to test all 4 probes for MYC-IGH fusion and rearrangement of MYC, BCL2, BCL6 is highly recommended.

The common gene rearrangements caused by chromosome translocations in each type of B-cell lymphoma are provided in Clinical Information as a reference for oncologists and pathologists. The oncologists and pathologists will decide which FISH probe to test according to diagnostic algorithms and patient clinical status. For gene rearrangements that are not provided by this test, specimens should be referred to Mayo Clinic Laboratories in Rochester, MN.

This assay is designed to detect the common gene rearrangements caused by chromosome abnormalities in tumor tissue as part of the pathologic diagnosis of B-cell lymphoma. The assay can be ordered as a panel, or each probe set can be ordered individually.

This test is not for blood or bone marrow specimens.

Advise Express Mail or equivalent if not on courier service.

Ship paraffin blocks on ice packs during warm months.

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.

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 not be accepted; provide fixation method used.

Additional Information: Paraffin-embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc).

Acceptable

Specimen Type: Tissue slides

Slides: 1 Hematoxylin and eosin-stained slide and 1 unstained slide for each probe set plus an additional unstained slide.

Collection Instructions:

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

2. For each probe set ordered, submit 1 consecutive, unstained, 4 to 5 micron-thick sections placed on positively charged slides, plus 1 additional unstained slide.

Slides: 1 Hematoxylin and eosin-stained slide and 1 unstained slide for each probe set

Providing essential information for an integrated pathologic diagnosis, an individualized treatment plan, and predicting patient response to treatment

This test is designed to detect the most common genomic changes in B-cell lymphoma including MYC-IGH fusion and rearrangement of MYC, BCL2, and BCL6 genes.

The oncologists and/or pathologists may order a single or all 4 fluorescence in situ hybridization (FISH) tests based on clinical needs. The lab will only perform the FISH tests that are ordered and report each separately within the same report. A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

Given the clinical importance of identifying the double-hit high grade B-cell lymphoma and the urgency of available results, one order to test all 4 probes for MYC-IGH fusion and rearrangement of MYC, BCL2, BCL6 is highly recommended.

The common gene rearrangements caused by chromosome translocations in each type of B-cell lymphoma are provided in Clinical Information as a reference for oncologists and pathologists. The oncologists and pathologists will decide which FISH probe to test according to diagnostic algorithms and patient clinical status. For gene rearrangements that are not provided by this test, specimens should be referred to Mayo Clinic Laboratories in Rochester, MN.

The common gene rearrangements in B-cell lymphoma caused by chromosome translocations (see Table). This test is designed to detect the rearrangement involving the MYC, BCL2, and BCL6 genes only.

Table. Common Chromosome Abnormalities in B-cell Lymphomas

An interpretive report will be provided.

The frequency of each gene rearrangement in a particular subtype of B-cell lymphoma varies from 100% to less than 10%; therefore, a negative result of a particular fluorescence in situ hybridization (FISH) test will not change the pathologic diagnosis.

MYC rearrangement is mainly caused by t(8;14)(q24.1;q32) translocation and less commonly by t(2;8)(p12;q24.1) and t(8;22)(q24.1;q11.2). The tri-color dual fusion probe detects MYC-IGH fusion caused by t(8;14). The dual color-MYC break apart probe used in this test detects the MYC rearrangement caused by all 3 different translocations. Similarly, the rearrangement of BCL2 and BCL6 have involved multiple partner genes, and these can be detected by BCL2 and BCL6 break apart probes.

The diffuse large B-cell lymphoma is associated with BCL2, BCL6, and MYC rearrangements. A double-hit (rarely triple-hit) high-grade B-cell lymphoma is identified when a tumor shows BCL2 or BCL6 rearrangement along with IGH-MYC fusion or other types of MYC rearrangement.

The FISH results will be correlated with clinical, pathological, and immunologic features by a pathologist for final interpretation.

This test is not approved by the US Food and Drug Administration and is best used as an adjunct to existing clinical and pathologic information.

Optimum fixation should be performed using 10% neutral buffered formalin. Other types of fixatives should not be used.

Paraffin-embedded tissues that have been decalcified are generally unsuccessful for fluorescence in situ hybridization analysis. Decalcified tissue will be rejected.

Each probe was independently tested on a set of formalin-fixed, paraffin-embedded tissue specimens from patients diagnosed with a B-cell lymphoma. Normal cutoffs were calculated based on the results from 20 normal specimens. For each probe set, a series of chromosomally abnormal specimens were evaluated to confirm each probe set detected the anomaly it was designed to detect.

Campo E, Harris NL, Jaffe ES, eds. WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC; 2017

This test is performed using commercially available probes. Rearrangements involving MYC, BCL2, or BCL6, are detected using dual-color break-apart probes. MYC-IGH fusion is identified using a tri-color dual-fusion probe. Formalin-fixed, paraffin-embedded tissues are cut between 4 to 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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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)