Test Catalog

Test Id : BLPMF

B-Cell Lymphoma, Specified FISH, Varies

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 lymphoma

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

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
BLPMB Probe, Each Additional (BLPMF) No, Bill Only No

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

This test includes a charge for application of the first probe set (2 fluorescence in situ hybridization [FISH] probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set.

 

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 B-cells are available for FISH testing. If the result does not identify a sufficient clonal B-cell population, this FISH test order will be canceled, and no charges will be incurred.

 

When specified, any of the following probes will be performed:

8q24.1 rearrangement, MYC break-apart

t(2;8)(p12;q24.1), IGK/MYC fusion

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

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

t(3q27;var) rearrangement, BCL6 break-apart

t(18q21;var) rearrangment, BCL2 break-apart

t(11;14)(q13;q32), CCND1/IGH fusion

-17/17p-, TP53/D17Z1

7q-, D7Z1/7q32

 

Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm is available. see Special Instructions.

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, Specified FISH

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

This test includes a charge for application of the first probe set (2 fluorescence in situ hybridization [FISH] probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set.

 

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 B-cells are available for FISH testing. If the result does not identify a sufficient clonal B-cell population, this FISH test order will be canceled, and no charges will be incurred.

 

When specified, any of the following probes will be performed:

8q24.1 rearrangement, MYC break-apart

t(2;8)(p12;q24.1), IGK/MYC fusion

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

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

t(3q27;var) rearrangement, BCL6 break-apart

t(18q21;var) rearrangment, BCL2 break-apart

t(11;14)(q13;q32), CCND1/IGH fusion

-17/17p-, TP53/D17Z1

7q-, D7Z1/7q32

 

Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm is available. see Special Instructions.

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

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

 

If specific probes are not included with this test order, the test may be canceled.

 

If either the break-apart MYC or the MYC/IGH D-FISH probe sets are requested in isolation, both probe sets will be performed concurrently to optimize the detection of MYC rearrangements.

 

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

 

For testing paraffin-embedded tissue samples from patients with B-cell lymphoblastic Lymphoma, see BLBLF / B-Cell Lymphoblastic Leukemia/Lymphoma, FISH, Tissue.

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

1. A list of probes requested for analysis is required. Probes available for this test are listed in the Testing Algorithm section.

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

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: 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.

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

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

Blood: 2 mL

Bone Marrow: 1 mL

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
Varies 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 lymphoma

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

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

This test includes a charge for application of the first probe set (2 fluorescence in situ hybridization [FISH] probes) and professional interpretation of results. Additional charges will be incurred for all reflex probes performed. Analysis charges will be incurred based on the number of cells analyzed per probe set.

 

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 B-cells are available for FISH testing. If the result does not identify a sufficient clonal B-cell population, this FISH test order will be canceled, and no charges will be incurred.

 

When specified, any of the following probes will be performed:

8q24.1 rearrangement, MYC break-apart

t(2;8)(p12;q24.1), IGK/MYC fusion

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

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

t(3q27;var) rearrangement, BCL6 break-apart

t(18q21;var) rearrangment, BCL2 break-apart

t(11;14)(q13;q32), CCND1/IGH fusion

-17/17p-, TP53/D17Z1

7q-, D7Z1/7q32

 

Bone Marrow Staging for Known or Suspected Malignant Lymphoma Algorithm is available. see Special Instructions.

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

Mature B-cell lymphomas represent a diverse group of neoplasms with a varied prognosis and clinical course based on the B-cell lymphoma subtype. Several characteristic genetic abnormalities have emerged as important diagnostic and prognostic markers in specific B-cell lymphoma subtypes (see Table).

 

Table. Common Chromosome Abnormalities in B-cell Lymphomas

Lymphoma subtype

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 (evaluated for exclusion)

3'/5' BCL6

18q21 rearrangement (evaluated for exclusion)

3'/5' BCL2

Diffuse large B-cell,

"double-hit" or

"triple hit"

8q24.1 rearrangement

5'/3' MYC

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

MYC/IGH

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

IGK/MYC

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

MYC/IGL

-Reflex: 3q27 rearrangement

3'/5' BCL6

-Reflex: 18q21 rearrangement

3'/5' BCL2

Follicular

18q21 rearrangement

3'/5' BCL2

3q27 rearrangement

3'/5' BCL6

Mantle cell

t(11;14)(q13;q32)

CCND1/IGH

-Reflex: 11q13 rearrangement

5'/3' CCND1

Blastoid subtype only: deletion of 17p

TP53/D17Z1

Blastoid subtype only: 8q24.1 rearrangement

5'/3' MYC

Blastoid subtype only: t(8;14)(q24.1;q32)

MYC/IGH

Splenic marginal zone lymphoma

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

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 lymphoma

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

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 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).

Supportive Data

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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

 

2. King RL, McPhail ED, Meyer RG, et al: False-negative rates for MYC fluorescence in situ hybridization probes in B-cell neoplasms Haematologica. Jun;104(6): e248-e251, 2019

 

3. Pophali PA, Marinelli LM, Ketterling RP, et al: High level MYC amplification in B-cell lymphomas: is it a marker of aggressive disease? Blood Cancer J. 2020 Jan 13;10(1):5

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 commercially available  and laboratory-developed  probes. Deletion of the 7q32 probe on chromosome 7 and the TP53 gene region on chromosome 17 are detected using enumeration strategy probes. Rearrangements involving MYC, BCL2 or BCL6 are detected using dual-color break-apart (BAP) strategy probes. Dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe sets are used to detect t(2;8), t(8;14), t(8;22), and t(11;14). For enumeration and BAP strategy probe sets, 100 interphase nuclei are scored; 200 interphase nuclei are scored when D-FISH probes are used, and results are 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.

7 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

4 weeks

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, and its performance characteristics 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.

88271 x2, 88275 x1, 88291 x1- FISH Probe, Analysis, Interpretation; 1 probe set

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

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