Test Catalog

Test Id : BLYM

B-Cell Lymphoma, FISH, Tissue

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with various B-cell lymphomas

 

Tracking known chromosome abnormalities and response to therapy in patients with B-cell lymphomas

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
_PRAA Probe, Each Additional (BLYM) No, (Bill Only) No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consultation. If a pathology consultation is desired, PATHC / Pathology Consultation should be ordered and the appropriate fluorescence in situ hybridization (FISH) test will be ordered 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.

 

Depending on the lymphoma subtype suspected, the most appropriate probes to order are listed in the table: Common Chromosome Abnormalities in B-cell Lymphomas in Clinical Information.

 

If the patient is being tracked for known abnormalities, indicate which probes should be used.

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

Initial probe sets are run and completed within 4 days. If, based on testing algorithms, results of the initial probe sets require reflex testing, complete results will be available within 10 days.

 

The following algorithms are available:

-Aggressive B-cell Lymphoma Diagnostic Algorithm

-Gastric MALT Lymphoma Diagnostic Algorithm

-Gastric MALT Posttherapy Follow-up Algorithm

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

B-cell Lymphoma, FISH, Tissue

Aliases
Lists additional common names for a test, as an aid in searching

BLYM

BCL2 (18q21) rearrangement

BCL6 (3q27) rearrangement

Burkitt lymphoma

Burkitt-like lymphoma

CCND2

Diffuse Large Cell Lymphoma/"Double Hit"

Follicular lymphoma

Large BCL with IRF4 rearranged

MALT (18q21) rearrangement

MALT lymphoma

Mantle Cell Lymphoma (MCL)

MYC (8q24.1) rearrangement

MYC/Kappa

Splenic Marginal Zone Lymphoma

t(11;14) (q13;q32) - CCND1/IGH

t(11;18) (q21;q21) - BIRC3/MALT1

t(14;18) (q32;q21) - IGH/MALT1

t(14;18)(q32;q21) - IGH/BCL2

t(2;8)(p12;q24) - IGK/MYC

t(8;14) (q24.1;q32) - MYC/IGH

IRF4

DUSP22

TNFRSF14

1p36

t(8;22) (q24.1;q11.2) - MYC/IGL

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consultation. If a pathology consultation is desired, PATHC / Pathology Consultation should be ordered and the appropriate fluorescence in situ hybridization (FISH) test will be ordered 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.

 

Depending on the lymphoma subtype suspected, the most appropriate probes to order are listed in the table: Common Chromosome Abnormalities in B-cell Lymphomas in Clinical Information.

 

If the patient is being tracked for known abnormalities, indicate which probes should be used.

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

Initial probe sets are run and completed within 4 days. If, based on testing algorithms, results of the initial probe sets require reflex testing, complete results will be available within 10 days.

 

The following algorithms are available:

-Aggressive B-cell Lymphoma Diagnostic Algorithm

-Gastric MALT Lymphoma Diagnostic Algorithm

-Gastric MALT Posttherapy Follow-up Algorithm

Specimen Type
Describes the specimen type validated for testing

Tissue

Ordering Guidance

This assay detects chromosome abnormalities observed in paraffin-embedded tissue samples of patients with B-cell lymphoma. If a blood or bone marrow specimen is submitted, the test will be canceled and BLPF / B-Cell Lymphoma, FISH, Varies will be added and performed as the appropriate test.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

A reason for testing and pathology report are required in order for testing to be performed. Send information with specimen. Acceptable pathology reports include working drafts, preliminary pathology or surgical pathology reports.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
GC026 Reason for Referral

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:

 

Specimen Type: Lymph node

Preferred: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

Acceptable: Slides

Collection Instructions: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

 

Specimen Type: Solid tumor

Preferred: Tissue block

Collection Instructions: Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.

Acceptable: Slides

Collection Instructions: For each probe set ordered, 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides, and 1 hematoxylin and eosin-stained slide.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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

Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with various B-cell lymphomas

 

Tracking known chromosome abnormalities and response to therapy in patients with B-cell lymphomas

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test does not include a pathology consultation. If a pathology consultation is desired, PATHC / Pathology Consultation should be ordered and the appropriate fluorescence in situ hybridization (FISH) test will be ordered 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.

 

Depending on the lymphoma subtype suspected, the most appropriate probes to order are listed in the table: Common Chromosome Abnormalities in B-cell Lymphomas in Clinical Information.

 

If the patient is being tracked for known abnormalities, indicate which probes should be used.

 

A charge and CPT code is applied for each probe set hybridized, analyzed, and reported.

 

Initial probe sets are run and completed within 4 days. If, based on testing algorithms, results of the initial probe sets require reflex testing, complete results will be available within 10 days.

 

The following algorithms are available:

-Aggressive B-cell Lymphoma Diagnostic Algorithm

-Gastric MALT Lymphoma Diagnostic Algorithm

-Gastric MALT Posttherapy Follow-up Algorithm

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Mature B-cell lymphoma can be low grade, intermediate grade, or high grade, and the prognosis and clinical course are highly variable. Genetic abnormalities have emerged as one of the most important prognostic markers in B-cell lymphomas and can aid in diagnosis. Several chromosome abnormalities and variants of these abnormalities have been associated with various lymphoma subtypes (see Table). Conventional chromosome studies cannot be employed on paraffin-embedded tissue, and molecular genetic analyses are often problematic in the study of lymphomas. FISH permits the detection of abnormal gene associated with various chromosome translocations and inversions in B-cell lymphoma (see Table).

 

 Table. Common Chromosome Abnormalities in B-cell Lymphomas

Lymphoma type

Chromosome abnormality

FISH probe

Burkitt (pediatric,

< or =18 years old)

8q24.1 rearrangement

5'/3' MYC

t(2;8)(p12;q24.1)

IGK/MYC

t(8;14)(q24.1;q32)

MYC/IGH

t(8;22)(q24.1;q11.2)

MYC/IGL

3q27 rearrangement

3'/5' BCL6

18q21 rearrangement

3'/5' BCL2

Diffuse large B-cell, Burkitt-like "double-hit"

8q24.1 rearrangement

5'/3' MYC

t(8;14)(q24.1;q32)

MYC/IGH

----Reflex: t(8;22)(q24.1;q11.2)

MYC/IGL

----Reflex: t(2;8)(p12;q24.1)

IGK/MYC

----Reflex: 3q27 rearrangement

3'/5' BCL6

----Reflex: 18q21 rearrangement

3'/5' BCL2

Large BCL with IRF4 rearranged

6p24.3 rearrangement

3'/5' IRF4

18q21 rearrangement

3'/5' BCL2

3q27 rearrangement

3'/5' BCL6

Follicular

18q21 rearrangement

3'/5' BCL2

3q27 rearrangement

3'/5' BCL6

Predominantly diffuse subtype only: deletion of 1p36

TNFRSF14/1q22

Mantle cell

t(11;14)(q13;q32)

CCND1/IGH

Blastoid subtype only: deletion of 17p

TP53/D17Z1

Blastoid subtype only: 8q24.1 rearrangement

5'/3' MYC

MALT

18q21 rearrangement

5'/3' MALT1

Splenic marginal zone

Deletion of 7q

D7Z1/7q32

Deletion of 17p

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

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 B-cell lymphoma. The specific abnormality detected may help subtype the neoplasm.

 

The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.

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 FDA, and it is best used as an adjunct to clinical and pathologic information.

 

Fixatives other than formalin (eg, Prefer, Bouin) may not be successful for fluorescence in situ hybridization (FISH) assays.

 

Paraffin-embedded tissues that have been decalcified are generally unsuccessful for FISH analysis. The pathologist reviewing the hematoxylin and eosin-stained slide may find it necessary to cancel testing.

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 and noncancerous lymph node specimens. Normal cutoffs were calculated based on the results from 25 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

Swerdlow SH, Campo E, Harris NL, eds, et al: WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. IARC; 2017

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Description
Describes how the test is performed and provides a method-specific reference

This test is performed using either commercially available or laboratory-developed probes. Rearrangements involving MYC, BCL2, BCL6, CCND2, IRF4, or MALT1 are detected using dual-color break-apart (BAP) strategy probes, translocations involving MYC, MALT1, or CCND1/IGH are identified using dual-color, dual-fusion (D-FISH) strategy probes, and deletions (7q32, TNFRSF14 (1p36), and TP53) using enumeration strategy probes. 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 100 interphase nuclei (200 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

No

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.

4 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Slides and H and E used for analysis are retained by the laboratory in accordance to CAP and NYS requirements. Client provided paraffin blocks and extra unstained slides (if provided) will be returned after testing is complete.

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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 Regional Manager. 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 using an analyte specific reagent. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test 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.

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)

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
BLYM B-cell Lymphoma, FISH, Tissue In Process
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.
603063 Result Summary 50397-9
603064 Interpretation 69965-2
603065 Result Table 93356-4
603066 Result 62356-1
GC026 Reason for Referral 42349-1
603067 Specimen 31208-2
603068 Source 85298-8
603069 Tissue ID 80398-1
603070 Method 85069-3
603071 Additional Information 48767-8
603072 Disclaimer 62364-5
603073 Released By 18771-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports