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Test ID LBOR0199 B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies


Ordering Guidance


This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol. If this test is ordered and the laboratory is informed that the patient is not on a COG protocol, this test will be canceled and automatically reordered by the laboratory as BALFP / Pediatric B-Lymphoblastic Leukemia/Lymphoma panel, FISH, Varies.

 

At follow-up, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and targeted B-cell ALL fluorescence in situ hybridization probes can be evaluated based on the abnormalities identified in the diagnostic study. Order BALMF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies and request specific probes or abnormalities.



Additional Testing Requirements


At diagnosis, conventional cytogenetic studies (COGBM / Chromosome Analysis, Hematologic Disorders, Children's Oncology Group Enrollment Testing, Bone Marrow) and this panel should be performed. If there is limited specimen available, only this test will be performed.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. Children's Oncology Group (COG) registration number and protocol number should be submitted with each specimen. The laboratory will not reject testing if this information is not provided; however, appropriate testing may be compromised or delayed.

2. 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.

3. A flow cytometry and/or a bone marrow pathology report should be submitted with each specimen. The laboratory will not reject testing if this information is not provided, but appropriate testing and interpretation may be compromised or delayed.

4. If the patient has received an opposite sex bone marrow transplant, note this information on the request.

5. If the patient has Down syndrome, note this information on the request.



Specimen Required


Submit only 1 of the following specimens:

 

Preferred

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (sodium heparin) or lavender top (EDTA)

Specimen Volume: 2 to 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.

3. Send bone marrow specimen in original tube. Do not aliquot.

 

Acceptable

Specimen Type: Whole blood

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (sodium heparin) or lavender top (EDTA)

Specimen Volume: 6 mL

Collection Instructions:

1. Invert several times to mix blood.

2. Send whole blood specimen in original tube. Do not aliquot.


Secondary ID

113530

Useful For

Detecting, at diagnosis, recurrent common chromosome abnormalities associated with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL) and BCR::ABL1-like acute lymphoblastic leukemia/lymphoma in patients being considered for enrollment in Children's Oncology Group (COG) clinical trials and research protocols

 

As an adjunct to conventional chromosome studies in pediatric patients with B-ALL and Ph-like ALL being considered for enrollment in COG protocols

 

Evaluating specimens in which chromosome studies are unsuccessful

 

This test should not be used to screen for residual B-ALL/LBL

Testing Algorithm

This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol. Additional charges will be incurred for all reflex or additional probe sets performed. Analysis charges will be incurred based on the number of cells analyzed per probe set. If no cells are available for analysis, no analysis charges will be incurred.

 

This test is performed as panel testing only using the following analysis algorithm.

 

The diagnostic pediatric/young adult B-cell acute lymphoblastic leukemia/lymphoma (B-ALL) fluorescence in situ hybridization (FISH) panel includes testing for the following abnormalities using the FISH probes listed:

CRLF2 (Xp22.33) or (Yp11.32) rearrangement, CRLF2 break-apart probe set

t(1;19)(q23;p13) or TCF3::PBX1 fusion, PBX1/TCF3 probe set

Hyperdiploidy or +4,+10,+17, D4Z1/D10Z1/D17Z1 probe set

t(8;14)(q24.21;q32) or IGH::MYC fusion, MYC/IGH probe set

t(8q24.21;var) or MYC rearrangement, MYC break-apart probe set

t(9;22)(q34;q11.2) or BCR::ABL1 fusion, ABL1/BCR probe set

t(11q23;var) or KMT2A rearrangement, KMT2A break-apart probe set

t(12;21)(p13;q22) or ETV6::RUNX1 fusion or iAMP21, ETV6/RUNX1 probe set

t(14q32;var) or IGH rearrangement, IGH break-apart probe set

 

If results for the initial panel are negative or demonstrate nonclassical abnormalities, the B-ALL with BCR::ABL1-like features panel will be performed as a secondary panel. This panel includes testing for the following kinase activating chromosome abnormalities, using the FISH probes listed below, as well as IKZF1 deletion, which often accompanies BCR::ABL1-like ALL.

t(1q25;var) or ABL2 rearrangement, ABL2 break-apart probe set

t(5q32;var) or PDGFRB rearrangement, PDGFRB break-apart probe set

t(9p24.1;var) or JAK2 rearrangement, JAK2 break-apart probe set

t(9q34;var) or ABL1 rearrangement, ABL1 break-apart probe set

7p- or IKZF1 deletion, IKZF1/CEP7 probe set

 

Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes used will have the results included within the final report and will be performed at an additional charge. In the following situations, additional (reflex) testing may be performed at the laboratory's discretion and may be influenced by available karyotype results or other FISH testing.

 

When a KMT2A rearrangement is identified, testing with 1 or more dual-fusion (D-FISH) probe sets in an attempt to identify the translocation partner for the following abnormalities:

t(4;11)(q21;q23) or KMT2A::AFF1 fusion, AFF1/KMT2A probe set

t(6;11)(q27;q23) or KMT2A::AFDN ;fusion, AFDN/KMT2A probe set

t(9;11)(p22;q23) or KMT2A::MLLT3 fusion, MLLT3/KMT2A probe set

t(10;11)(p12;q23) or KMT2A::MLLT10 fusion, MLLT10/KMT2A probe set

t(11;19)(q23;p13.1) or KMT2A::MLLT1 fusion, KMT2A/ELL probe set

t(11;19)(q23;p13.3) or KMT2A::ELL fusion, KMT2A/MLLT1 probe set

 

When an unbalanced CRLF2 rearrangement is identified concurrently with an IGH rearrangement, testing will be performed using the CRLF2/IGH probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14)(p11.32;q32) cryptic translocation may be performed.

 

In the absence of BCR::ABL1 fusion, when an extra or atypical ABL1 signal is identified, testing using the ABL1 break-apart probe set to identify a potential variant translocation involving ABL1, t(9;var)(q34;?) may be performed.

 

In the absence of ETV6::RUNX1 fusion, when an extra ETV6 signal is identified, testing using the ETV6 break-apart probe set to evaluate for the presence or absence of a potential rearrangement involving ETV6 t(12;var)(p13;?) may be performed.

 

When a MYC rearrangement is identified, both the BCL2 and BCL6 break-apart probe sets will be performed.

 

If an unbalanced rearrangement of BCL2 is identified, testing using the IGH/BCL2 probe to identify a potential t(14;18)(q32;q21) or IGH::BCL2 fusion may be performed.

 

For more information see B-Lymphoblastic Leukemia/Lymphoma Genetic Testing Guidelines.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

COG, ALL (B-cell), FISH

Specimen Type

Varies

Specimen Minimum Volume

Bone marrow: 1 mL; Whole blood: 2 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient (preferred)
  Refrigerated 

Reject Due To

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

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

88271 x 2, 88275, 88291-FISH Probe, Analysis, Interpretation; 1 probe set

88271 x 2, 88275-FISH Probe, Analysis; each additional probe set (if appropriate)

Forms

If not ordering electronically, complete, print, and send a Children's Oncology Group Test Request (T829) with the specimen.