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25028 B-Cell Acute Lymphoblastic Leukemia, FISH (BALLF)

B-Cell Acute Lymphoblastic Leukemia, FISH (BALLF)
Test Code: MISC
Synonyms/Keywords
​Ref Lab Code: 81616, +4,+10, +17, 11q23 (MLL), 14q32 (IGH), Acute Lymphoblastic Leukemia (ALL), Adult Acute Lymphoblastic Leukemia (ALL), CDKN2A/Cen9, del(9p) (p16), Hyperdiploidy, p16, Pediatric Acute Lymphoblastic Leukemia (ALL), t(1;19) (PBX1/TCF3), t(12;21) (TEL/AML1), t(9;22) (BCR/ABL), TEL/AML1, ETV6/RUNX1, 17p- (17p deletion) or TP53, 9p- (9p deletion) or CDKN2A or p16, Hyperdiploidy, IGH (14q32) rearrangement, t(11;19)(q23;p13.1) - MLL/ELL, t(11;19)(q23;p13.3) - MLL/MLLT1 or MLL/ENL, t(4;11)(q21;q23) - AFF1/MLL or AF4/MLL, t(9;11)(p22;q23) - MLLT3/ML or AF9/MLL, t(X;14)(p22.3;q32) - CRLF2/IGH, t(Y;14)(p11.32;q32) - CRLF2/IGH, t(6;11)(q27; q23) - MLLT4/MLL or AF6/MLL, t(10;11)(p12;q23) - MLLT10/MLL or AF10/MLL, MYC (8q24.1) rearrangement, ABL2 (1q25) rearrangement, PDGFRB (5q33) rearrangement, JAK2 (9p24.1) rearrangement, ABL1(9Q34) rearrangement, CRLF2 (Xp22.33) or (Yp11.32) rearrangement, P2RY8 (Xp22.33) or Yp11.32) rearrangement, Ph-like ALL, BCR-ABL1 like ALL, iAMP21, Hypodiploidy/pseudo-hyperdiploid, Hyproiploid/Near-Triploid
Test Components

​This B-cell acute lymphoblastic leukemia (B-ALL) FISH test may be ordered in 4 distinct ways allowing different combinations of probes to be utilized based on the clinical question.  the 4 ways this B-ALL FISH test can be ordered are as follows:

1.  Standard (diagnostic) B-ALL FISH panelStandard (diagnostic) B-ALL FISH panel

2.  Philadelphia chromosome-like acute lymphblastic leukemia (Ph-like ALL) panelPhiladelphia chromosome-like acute lymphblastic leukemia (Ph-like ALL) panel

3.  Combined-Standard (diagnostic) B-ALL FISH panel + Ph-like ALL panel

4.  Individual B-ALL FISH probes (per client request)

The specific B-ALL FISH panel or FISH probes requested must be noted on the request form or in the reason for referral. If no specific panel or FISH probe request is indicated, the "Standard (diagnostic) B-ALL FISH panel" will be performed.

The Standard (diagnostic) B-ALL FISH panel includes testing for the following abnormalities, using the FISH probes listed:
 
Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1
t(12;21)(p13;q22), ETV6/RUNX1 fusion, ETV6/RUNX1 D-FISH
iAMP21, RUNX1 amplification, ETV6/RUNX1 D-FISH
t(9;22)(q34;q11.2), BCR/ABL1 fusion, BCR/ABL1 D-FISH
t(1;19)(q23;p13), PBX1/TCF3 fusion, PBX1/TCF3 D-FISH
t(11q23;var), MLL (KMT2A) rearrangement, MLL (KMT2A) break-apart
del(9p), CDKN2A deletions, CDKN2A/D9Z1
t(14q32;var), IGH rearrangement, IGH break-apart
del(17p), TP53 deletions, TP53/D17Z1
8q24.1 rearrangement, MYC break-apart
t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement, P2RY8 break-apart
t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement, CRLF2 break-apart
 
-When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of t(4;11)(q21;q23) AFF1/MLL, t(6;11)(q27;q23) MLLT4/MLL, t(9;11)(p22;q23) MLLT3/MLL, t(10;11)(p13;q23) MLLT10/MLL, t(11;19)(q23;p13.1) MLL/ELL, or t(11;19)(q23;p13.3) MLL/MLLT1.
-When an IGH and/or CRLF rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14) (p11.32;q32) "cryptic translocation."

​​

The Philadelphia Ph-like ALL panel includes testing for the following kinase activating chromosome abnormalities, using the FISH probes listed:
-t(1q25;var), ABL2 rearrangement, ABL2 break-apart
-t(5q33;var), PDGFRB rearrangement, PDGFRB break-apart
-t(9p24.1;var), JAK2 rearrangement, JAK2 break-apart
-t(9q34;var), ABL1 rearrangement, ABL1 break-apart
-t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement, P2RY8 break-apart
-t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement, CRLF2 break-apart
 
-When a PDGFRB rearrangement is identified, reflex testing will be performed using the PDGFRB/ETV6 fusion probe set to identify the potential t(5;12)(q33;p13) translocation.
-When a CRLF rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14) (p11.32;q32) "cryptic translocation."
 
 
This test includes a charge for application of the first probe set (2 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. If no cells are available for analysis, no analysis charges will be incurred.
 
We recommend the following testing algorithm for patients with B-acute lymphoblastic leukemia (B-ALL):
-At diagnosis, standard (diagnostic) B-ALL FISH panel and/or conventional chromosome studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) should be performed. If there is limited specimen available, the BALLF test will be performed.
-If the patient clinically relapses, a conventional chromosome study is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone.
 
Useful For
Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with B-cell acute lymphoblastic leukemia (B-ALL) and Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL)
 
Identifying and tracking known chromosome abnormalities in patients with B-ALL and Ph-like ALL and tracking response to therapy.
 
As an adjunct to conventional chromosome studies in patients with B-ALL and Ph-like ALL
 
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Submit only 1 of the following specimens:​ ​ ​ ​ ​ ​
Blood ​Sodium Heparin Green Top Tube (GTT) ​ ​7-10 mL 2 mL​ ​
​Bone marrow Sodium Heparin Green Top Tube (GTT)​ ​ 1-2 mL​ ​1 mL ​
Collection Processing Instructions
Provide a reason for referral 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.
 
Blood:
1. Invert several times to mix blood.
2. Other anticoagulants are not recommended and are harmful to the viability of the cells.
 
Bone marrow: 
1. Invert several times to mix bone marrow.
2. Other anticoagulants are not recommended and are harmful to the viability of the cells
Specimen Stability Information
Specimen Type Temperature
​Varies ​ ​Ambient (preferred)
​Refrigerated
Rejection Criteria
Clotted blood or bone marrow
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories Monday through Friday​ ​7 days
Fluorescence In Situ Hybridization (FISH) with DNA Probes​
Reference Lab
Mayo Clinic Laboratories
Test Information

The B-acute lymphoblastic leukemia (B-ALL) FISH test is performed using commercially available and laboratory-developed probes. Deletion of the CDKN2A locus on chromosome 9 and TP53 on chromosome 17 and gain of chromosomes 4, 10, and 17 are detected using enumeration strategy probes. Rearrangements involving MLL, IGH, and MYC are detected using a dual-color break-apart (BAP) strategy probe. Dual-color, dual-fusion (D-FISH) strategy probe sets are used to detect t(9;22), t(12;21), t(1;19), and in reflex testing when rearrangements of the MLL and IGH genes are detected. If the Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) probes are requested, the test is performed using commercially available and laboratory-developed probes. Rearrangements involving ABL2, PDGFRB, JAK2, ABL1, CRLF2 and P2RY8 are detected using a dual-color break-apart (BAP) strategy probe. For enumeration and BAP strategy probe sets, 200 interphase nuclei are scored; 500 interphase nuclei are scored when D-FISH probes are used. Two technologists analyze each probe set and all results are expressed as the percent abnormal nuclei.

​
Note: Additional probes may be needed and will be added at an additional charge (and CPT).

Reference Range Information
Interpretive report
Interpretation
A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.
 
The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88291 ​ 1 ​Interpretation and report ​
​​88271 ​ 2 ​DNA Probes
​88271 ​ ​2 Probe Set, Count ​​​​as needed
​​88271 ​ ​1 ​Probe, +1 ​​​​as needed
​​88271 ​ ​2 ​Probe, +2 ​​​​as needed
​​88271 ​ ​3 ​Probe, +3 ​​​​as needed
​​88274 ​ ​1 ​Interphases, <25​ ​​​​as needed
​​88274 ​ ​1 ​Interphases, 25-99 ​​​​as needed
​​88275 ​ ​1 ​Interphases, 100-300 ​​​​as needed
Synonyms/Keywords
​Ref Lab Code: 81616, +4,+10, +17, 11q23 (MLL), 14q32 (IGH), Acute Lymphoblastic Leukemia (ALL), Adult Acute Lymphoblastic Leukemia (ALL), CDKN2A/Cen9, del(9p) (p16), Hyperdiploidy, p16, Pediatric Acute Lymphoblastic Leukemia (ALL), t(1;19) (PBX1/TCF3), t(12;21) (TEL/AML1), t(9;22) (BCR/ABL), TEL/AML1, ETV6/RUNX1, 17p- (17p deletion) or TP53, 9p- (9p deletion) or CDKN2A or p16, Hyperdiploidy, IGH (14q32) rearrangement, t(11;19)(q23;p13.1) - MLL/ELL, t(11;19)(q23;p13.3) - MLL/MLLT1 or MLL/ENL, t(4;11)(q21;q23) - AFF1/MLL or AF4/MLL, t(9;11)(p22;q23) - MLLT3/ML or AF9/MLL, t(X;14)(p22.3;q32) - CRLF2/IGH, t(Y;14)(p11.32;q32) - CRLF2/IGH, t(6;11)(q27; q23) - MLLT4/MLL or AF6/MLL, t(10;11)(p12;q23) - MLLT10/MLL or AF10/MLL, MYC (8q24.1) rearrangement, ABL2 (1q25) rearrangement, PDGFRB (5q33) rearrangement, JAK2 (9p24.1) rearrangement, ABL1(9Q34) rearrangement, CRLF2 (Xp22.33) or (Yp11.32) rearrangement, P2RY8 (Xp22.33) or Yp11.32) rearrangement, Ph-like ALL, BCR-ABL1 like ALL, iAMP21, Hypodiploidy/pseudo-hyperdiploid, Hyproiploid/Near-Triploid
Test Components

​This B-cell acute lymphoblastic leukemia (B-ALL) FISH test may be ordered in 4 distinct ways allowing different combinations of probes to be utilized based on the clinical question.  the 4 ways this B-ALL FISH test can be ordered are as follows:

1.  Standard (diagnostic) B-ALL FISH panelStandard (diagnostic) B-ALL FISH panel

2.  Philadelphia chromosome-like acute lymphblastic leukemia (Ph-like ALL) panelPhiladelphia chromosome-like acute lymphblastic leukemia (Ph-like ALL) panel

3.  Combined-Standard (diagnostic) B-ALL FISH panel + Ph-like ALL panel

4.  Individual B-ALL FISH probes (per client request)

The specific B-ALL FISH panel or FISH probes requested must be noted on the request form or in the reason for referral. If no specific panel or FISH probe request is indicated, the "Standard (diagnostic) B-ALL FISH panel" will be performed.

The Standard (diagnostic) B-ALL FISH panel includes testing for the following abnormalities, using the FISH probes listed:
 
Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1
t(12;21)(p13;q22), ETV6/RUNX1 fusion, ETV6/RUNX1 D-FISH
iAMP21, RUNX1 amplification, ETV6/RUNX1 D-FISH
t(9;22)(q34;q11.2), BCR/ABL1 fusion, BCR/ABL1 D-FISH
t(1;19)(q23;p13), PBX1/TCF3 fusion, PBX1/TCF3 D-FISH
t(11q23;var), MLL (KMT2A) rearrangement, MLL (KMT2A) break-apart
del(9p), CDKN2A deletions, CDKN2A/D9Z1
t(14q32;var), IGH rearrangement, IGH break-apart
del(17p), TP53 deletions, TP53/D17Z1
8q24.1 rearrangement, MYC break-apart
t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement, P2RY8 break-apart
t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement, CRLF2 break-apart
 
-When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of t(4;11)(q21;q23) AFF1/MLL, t(6;11)(q27;q23) MLLT4/MLL, t(9;11)(p22;q23) MLLT3/MLL, t(10;11)(p13;q23) MLLT10/MLL, t(11;19)(q23;p13.1) MLL/ELL, or t(11;19)(q23;p13.3) MLL/MLLT1.
-When an IGH and/or CRLF rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14) (p11.32;q32) "cryptic translocation."

​​

The Philadelphia Ph-like ALL panel includes testing for the following kinase activating chromosome abnormalities, using the FISH probes listed:
-t(1q25;var), ABL2 rearrangement, ABL2 break-apart
-t(5q33;var), PDGFRB rearrangement, PDGFRB break-apart
-t(9p24.1;var), JAK2 rearrangement, JAK2 break-apart
-t(9q34;var), ABL1 rearrangement, ABL1 break-apart
-t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement, P2RY8 break-apart
-t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement, CRLF2 break-apart
 
-When a PDGFRB rearrangement is identified, reflex testing will be performed using the PDGFRB/ETV6 fusion probe set to identify the potential t(5;12)(q33;p13) translocation.
-When a CRLF rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14) (p11.32;q32) "cryptic translocation."
 
 
This test includes a charge for application of the first probe set (2 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. If no cells are available for analysis, no analysis charges will be incurred.
 
We recommend the following testing algorithm for patients with B-acute lymphoblastic leukemia (B-ALL):
-At diagnosis, standard (diagnostic) B-ALL FISH panel and/or conventional chromosome studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) should be performed. If there is limited specimen available, the BALLF test will be performed.
-If the patient clinically relapses, a conventional chromosome study is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone.
 
Ordering Applications
Ordering Application Description
​Centricity ​B-Cell Acute Lymphoblastic Leuk, FISH
​Cerner ​B-Cell Acute Lymphoblast, FISH (81616)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)		 Pediatric Minimum Volume
(no repeat)
Submit only 1 of the following specimens:​ ​ ​ ​ ​ ​
Blood ​Sodium Heparin Green Top Tube (GTT) ​ ​7-10 mL 2 mL​ ​
​Bone marrow Sodium Heparin Green Top Tube (GTT)​ ​ 1-2 mL​ ​1 mL ​
Collection Processing
Provide a reason for referral 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.
 
Blood:
1. Invert several times to mix blood.
2. Other anticoagulants are not recommended and are harmful to the viability of the cells.
 
Bone marrow: 
1. Invert several times to mix bone marrow.
2. Other anticoagulants are not recommended and are harmful to the viability of the cells
Specimen Stability Information
Specimen Type Temperature
​Varies ​ ​Ambient (preferred)
​Refrigerated
Rejection Criteria
Clotted blood or bone marrow
Useful For
Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with B-cell acute lymphoblastic leukemia (B-ALL) and Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL)
 
Identifying and tracking known chromosome abnormalities in patients with B-ALL and Ph-like ALL and tracking response to therapy.
 
As an adjunct to conventional chromosome studies in patients with B-ALL and Ph-like ALL
 
Test Components

​This B-cell acute lymphoblastic leukemia (B-ALL) FISH test may be ordered in 4 distinct ways allowing different combinations of probes to be utilized based on the clinical question.  the 4 ways this B-ALL FISH test can be ordered are as follows:

1.  Standard (diagnostic) B-ALL FISH panelStandard (diagnostic) B-ALL FISH panel

2.  Philadelphia chromosome-like acute lymphblastic leukemia (Ph-like ALL) panelPhiladelphia chromosome-like acute lymphblastic leukemia (Ph-like ALL) panel

3.  Combined-Standard (diagnostic) B-ALL FISH panel + Ph-like ALL panel

4.  Individual B-ALL FISH probes (per client request)

The specific B-ALL FISH panel or FISH probes requested must be noted on the request form or in the reason for referral. If no specific panel or FISH probe request is indicated, the "Standard (diagnostic) B-ALL FISH panel" will be performed.

The Standard (diagnostic) B-ALL FISH panel includes testing for the following abnormalities, using the FISH probes listed:
 
Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1
t(12;21)(p13;q22), ETV6/RUNX1 fusion, ETV6/RUNX1 D-FISH
iAMP21, RUNX1 amplification, ETV6/RUNX1 D-FISH
t(9;22)(q34;q11.2), BCR/ABL1 fusion, BCR/ABL1 D-FISH
t(1;19)(q23;p13), PBX1/TCF3 fusion, PBX1/TCF3 D-FISH
t(11q23;var), MLL (KMT2A) rearrangement, MLL (KMT2A) break-apart
del(9p), CDKN2A deletions, CDKN2A/D9Z1
t(14q32;var), IGH rearrangement, IGH break-apart
del(17p), TP53 deletions, TP53/D17Z1
8q24.1 rearrangement, MYC break-apart
t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement, P2RY8 break-apart
t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement, CRLF2 break-apart
 
-When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of t(4;11)(q21;q23) AFF1/MLL, t(6;11)(q27;q23) MLLT4/MLL, t(9;11)(p22;q23) MLLT3/MLL, t(10;11)(p13;q23) MLLT10/MLL, t(11;19)(q23;p13.1) MLL/ELL, or t(11;19)(q23;p13.3) MLL/MLLT1.
-When an IGH and/or CRLF rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14) (p11.32;q32) "cryptic translocation."

​​

The Philadelphia Ph-like ALL panel includes testing for the following kinase activating chromosome abnormalities, using the FISH probes listed:
-t(1q25;var), ABL2 rearrangement, ABL2 break-apart
-t(5q33;var), PDGFRB rearrangement, PDGFRB break-apart
-t(9p24.1;var), JAK2 rearrangement, JAK2 break-apart
-t(9q34;var), ABL1 rearrangement, ABL1 break-apart
-t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement, P2RY8 break-apart
-t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement, CRLF2 break-apart
 
-When a PDGFRB rearrangement is identified, reflex testing will be performed using the PDGFRB/ETV6 fusion probe set to identify the potential t(5;12)(q33;p13) translocation.
-When a CRLF rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14) (p11.32;q32) "cryptic translocation."
 
 
This test includes a charge for application of the first probe set (2 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. If no cells are available for analysis, no analysis charges will be incurred.
 
We recommend the following testing algorithm for patients with B-acute lymphoblastic leukemia (B-ALL):
-At diagnosis, standard (diagnostic) B-ALL FISH panel and/or conventional chromosome studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) should be performed. If there is limited specimen available, the BALLF test will be performed.
-If the patient clinically relapses, a conventional chromosome study is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone.
 
Reference Range Information
Interpretive report
Interpretation
A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.
 
The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.
For more information visit:
Performing Laboratory Information
Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
​Mayo Medical Laboratories Monday through Friday​ ​7 days
Fluorescence In Situ Hybridization (FISH) with DNA Probes​
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPT Modifier
(if needed)		 Quantity Description Comments
​88291 ​ 1 ​Interpretation and report ​
​​88271 ​ 2 ​DNA Probes
​88271 ​ ​2 Probe Set, Count ​​​​as needed
​​88271 ​ ​1 ​Probe, +1 ​​​​as needed
​​88271 ​ ​2 ​Probe, +2 ​​​​as needed
​​88271 ​ ​3 ​Probe, +3 ​​​​as needed
​​88274 ​ ​1 ​Interphases, <25​ ​​​​as needed
​​88274 ​ ​1 ​Interphases, 25-99 ​​​​as needed
​​88275 ​ ​1 ​Interphases, 100-300 ​​​​as needed
For most current information refer to the Marshfield Laboratory online reference manual.