Test Id : JLYMF
B-Cell Lymphoma, FISH, Tissue
Useful For
Suggests clinical disorders or settings where the test may be helpful
Providing essential information for an integrated pathologic diagnosis, an individualized treatment plan, and predicting patient response to treatment
Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.
| Test Id | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| JLYMP | Probe, Each Additional (JLYMF)-PC | No | No |
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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.
Method Name
A short description of the method used to perform the test
Fluorescence In Situ Hybridization (FISH)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
BCL2 (18q21) rearrangement
BCL6 (3q27) rearrangement
BLYM
Burkitt lymphoma
Burkitt-like lymphoma
Diffuse Large Cell Lymphoma/"Double Hit"
JLYMF
MYC (8q24.1) rearrangement
t(8;14) (q24.1;q32) - MYC/IGH
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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.
Specimen Type
Describes the specimen type validated for testing
Tissue
Ordering Guidance
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.
Shipping Instructions
Advise Express Mail or equivalent if not on courier service.
Ship paraffin blocks on ice packs during warm months.
Necessary Information
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.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Forms
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Slides: 1 Hematoxylin and eosin-stained slide and 1 unstained slide for each probe set
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Decalcified specimens | Reject |
| Non-Formalin fixed, paraffin embedded tissue samples | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Tissue | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Providing essential information for an integrated pathologic diagnosis, an individualized treatment plan, and predicting patient response to treatment
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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
| Lymphoma type | Genomic changes | FISH probe |
| Burkitt (pediatric, | MYC rearrangement | 5'/3' MYC |
| MYC-IGH fusion | MYC/IGH | |
| BCL6 rearrangement | 3'/5' BCL6 | |
| BCL2 rearrangement | 3'/5' BCL2 | |
| Diffuse large B-cell and double-hit high grade | MYC rearrangement | 5'/3' MYC |
| MYC-IGH fusion | MYC/IGH | |
| BCL6 rearrangement | 3'/5' BCL6 | |
| BCL2 rearrangement | 3'/5' BCL2 | |
| Large BCL with IRF4 rearranged | 6p24.3 rearrangement | 3'/5' IRF4 |
| BCL2 rearrangement | 3'/5' BCL2 | |
| BCL6 rearrangement | 3'/5' BCL6 | |
| Follicular | BCL2 rearrangement | 3'/5' BCL2 |
| BCL6 rearrangement | 3'/5' BCL6 | |
| Predominantly diffuse subtype only: 1p36 deletion | 1p36.1/1q22 | |
| Mantle cell | CCND1-IGH fusion | CCND1/IGH |
| Blastoid subtype only: 17p deletion | TP53/D17Z1 | |
| Blastoid subtype only: MYC rearrangement | 5'/3' MYC | |
| MALT | MALT1 rearrangement | 5'/3' MALT1 |
| Splenic marginal zone | 7q deletion | D7Z1/7q32 |
| 17p deletion | TP53/D17Z1 |
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
An interpretive report will be provided.
Interpretation
Provides information to assist in interpretation of the test results
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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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.
Supportive Data
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.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
Campo E, Harris NL, Jaffe ES, eds. WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues. IARC; 2017
Method Description
Describes how the test is performed and provides a method-specific reference
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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- 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.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
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)
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| JLYMF | B Cell Lymphoma, FISH, Tissue | 101787-0 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| 614554 | Result Summary | 50397-9 |
| 614555 | Interpretation | 59465-5 |
| 614557 | Result | 82939-0 |
| 614558 | Reason for Referral | 42349-1 |
| 614559 | Specimen | 31208-2 |
| 614560 | Source | 31208-2 |
| 614561 | Tissue ID | 80398-1 |
| 614562 | Method | 85069-3 |
| 614563 | Additional Information | 48767-8 |
| 614912 | Disclaimer | 62364-5 |
| 614913 | Released By | 18771-6 |