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Test Code BALFP Pediatric B-Lymphoblastic Leukemia/Lymphoma Panel, FISH, Varies


Ordering Guidance


This test is only performed on specimens from patients with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) who are aged 30 years or younger.

 

This test is intended to be ordered when the entire B-ALL fluorescence in situ hybridization (FISH) panel is needed for a pediatric patient.

 

This test should NOT be used to screen for residual B-ALL/LBL. At follow-up, or if the patient clinically relapses, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone. Additionally, targeted B-ALL FISH probes can be evaluated based on the abnormalities identified in the diagnostic study.

 

If targeted B-cell ALL FISH probes are preferred, order BALMF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies, and request specific probes for targeted abnormalities.

 

If this test is ordered on a patient aged 31 years or older, this test will be canceled and automatically reordered by the laboratory as BALAF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies.

 

If this test is ordered and the laboratory is informed that the patient is on a Children's Oncology Group (COG) protocol, this test will be canceled and automatically reordered by the laboratory as COGBF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies.

 

If either AMLFP / Pediatric Acute Myeloid Leukemia Panel, FISH, Varies; or TALFP / Pediatric T-Lymphoblastic Leukemia/Lymphoma Panel, FISH, Varies, is ordered concurrently with this test, the laboratory may cancel this test and automatically reorder as BALMF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies with the following FISH probes: ETV6/RUNX1, PBX1/TCF3, 4/10/17, break-apart IGH, break-apart CRLF2, break-apart MYC, break-apart ABL2, break-apart PDGFRB, break-apart JAK2, break-apart ABL1, and IKZF1/cep7. If an abnormality is identified that would result in reflex testing in BALFP, the same reflex testing will be performed in the BALMF. This cancellation is necessary to avoid duplicate testing. Probes for ABL1/BCR and break-apart KMT2A will still be performed as part of the pediatric T-ALL FISH panel.

 

If PHLFD / B-Lymphoblastic Leukemia/Lymphoma with BCR::ABL1-like Features Panel, FISH, Varies, is ordered concurrently with this test, PHLDF testing will be canceled. This cancellation is necessary to avoid duplicate testing as PHLDF probes are included within this test, when appropriate.

 

For patients with B-cell lymphoma, order BLPMF / B-Cell Lymphoma, Specified FISH, Varies.

 

For testing paraffin-embedded tissue samples from patients with B-LBL, order BLBLF / B-Cell Lymphoblastic Leukemia/Lymphoma, FISH, Tissue. If a paraffin-embedded tissue sample is submitted for this test, it will be canceled and BLBLF will be added and performed as the appropriate test.



Additional Testing Requirements


At diagnosis, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and this fluorescence in situ hybridization 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. 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.

2. 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.

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

4. 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

622400

Useful For

Detecting, at diagnosis, recurrent common chromosome abnormalities associated with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) and BCR::ABL1-like B-ALL in pediatric/young adult patients using a laboratory-designated probe set algorithm

 

As an adjunct to conventional chromosome studies in pediatric/young adult patients with B-ALL

 

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 includes a charge for the probe application, analysis, and professional interpretation of results for 9 probe sets (19 individual fluorescence in situ hybridization [FISH] probes). 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-lymphoblastic leukemia (B-ALL) 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-lymphoblastic leukemia/lymphoma 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 FISH (D-FISH) probe sets may be performed 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 using the CRLF2/IGH probe set will be considered to identify a potential t(X;14)(p22.33;q32) or t(Y;14)(p11.32;q32) cryptic translocation.

 

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

 

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

 

When a MYC rearrangement is identified, testing using 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 set will be considered to identify a potential t(14;18)(q32;q21) or IGH::BCL2 fusion.

 

For more information see B-Lymphoblastic Leukemia/Lymphoma Algorithm.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

Pediatric B-ALL/LBL panel, 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 x18, 88275 x9, 88291 x1-FISH Probe, Analysis, Interpretation; 9 probe sets

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BALFP Pediatric B-ALL/LBL panel, FISH 102100-5

 

Result ID Test Result Name Result LOINC Value
622401 Result Summary 50397-9
622402 Interpretation 69965-2
622403 Result Table 93356-4
622404 Result 62356-1
GC153 Reason for Referral 42349-1
GC154 Specimen 31208-2
622405 Source 31208-2
622406 Method 85069-3
622407 Additional Information 48767-8
622408 Disclaimer 62364-5
622409 Released By 18771-6