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Test Code BLBLF B-Cell Lymphoblastic Leukemia/Lymphoma, FISH, Tissue


Ordering Guidance


This test does not include a pathology consultation. If a pathology consultation is requested, order PATHC / Pathology Consultation, and appropriate testing will be added at the discretion of the pathologist and performed at an additional charge.

 

Mayo Clinic Hematopathology consultants are involved in the pre-analytic phase (tissue adequacy and probe selection, when applicable).

 

This test is not appropriate for testing blood and bone marrow from patients with B-lymphoblastic leukemia/lymphoma. If a non-paraffin embedded bone marrow or blood sample is received for this test, the test will be canceled and automatically reordered by the laboratory as BALAF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies or BALFP / Pediatric B-Lymphoblastic Leukemia/Lymphoma Panel, FISH, Varies depending on the age of the patient.



Shipping Instructions


Advise Express Mail or equivalent if not on courier service.



Necessary Information


1. A pathology report is required for testing to be performed. If not provided, appropriate testing and/or interpretation may be compromised or delayed. Acceptable pathology reports include working drafts, preliminary pathology, or surgical pathology reports.

2. The following information must be included in the report provided:

-Patient name

-Block number - must be on all blocks, slides, and paperwork

-Date of collection

-Tissue source

3. 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.

4. A list of probes is required if select probes are necessary or if the patient is being tracked for known abnormalities. See Table in Clinical Information.



Specimen Required


Submit only 1 of the following specimens:

 

Preferred

Specimen Type: Tissue block

Collection Instructions:

1. Submit a formalin-fixed, paraffin-embedded tumor tissue block. Blocks prepared with alternative fixation methods will be attempted but are less favorable for successful results.

2. Provide fixation method used.

Additional Information:

1. Paraffin embedded specimens can be from any anatomic location (skin, soft tissue, lymph node, etc).

2. Bone specimens that have been decalcified will be attempted for testing, but the success rate is approximately 50%.

 

Acceptable

Specimen Type: Tissue slides

Slides: 1 Hematoxylin and eosin stained and 2 unstained for each probe set

Collection Instructions:

1. Include 1 hematoxylin and eosin-stained slide for the entire test order.

2. If individual probe sets are chosen: For each probe set ordered, submit 2 consecutive, unstained, 5 micron-thick sections placed on positively charged slides.

3. If a complete B-lymphoblastic leukemia/lymphoma (BLBL) panel is ordered: Submit 20 consecutive, unstained, 5 micron-thick sections placed on positively charged slides.


Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Hematopathology/Cytogenetics Test Request (T726)

-Children's Oncology Group Test Request (T829)

Useful For

Detecting, at diagnosis, recurrent common chromosome abnormalities associated with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) and Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) in paraffin-embedded specimens

 

Monitoring response to therapy by tracking known chromosome abnormalities in patients with B-ALL/LBL

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
_IL25 Interphases, <25 No, (Bill Only) No
_I099 Interphases, 25-99 No, (Bill Only) No
_I300 Interphases, >=100 No, (Bill Only) No
_PADD Probe, +1 No, (Bill Only) No
_PB02 Probe, +2 No, (Bill Only) No
_PB03 Probe, +3 No, (Bill Only) No
_PBCT Probe, +2 No, (Bill Only) No

Testing Algorithm

This test includes a charge for the probe application, analysis, and professional interpretation of results for one probe set (2 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 may be ordered in 2 distinct ways allowing different combinations of probes to be analyzed based on the clinical question.

1. Standard (diagnostic) B-lymphoblastic leukemia/lymphoma (BLBL) FISH panel

2. Individual BLBL FISH probes chosen, per client request, from probes listed below

 

If individual BLBL FISH probes are wanted, the specific probes requested must be noted on the request form or in the reason for referral. If no FISH probes are indicated, the standard (diagnostic) panel will be performed.

 

The standard (diagnostic) panel for patients aged 30 years or younger includes testing for the following abnormalities, using the FISH probes listed:

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

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

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

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

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

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

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

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

 

If results for the initial panel are negative or demonstrate nonclassical abnormalities, the Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) panel will be performed as a secondary panel. The Ph-like ALL panel includes testing for the following kinase activating chromosome abnormalities, using the FISH probes listed below:

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

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

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

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

 

The FISH initial (diagnostic) panel for patients aged 31 years or older includes testing with the following FISH probe: t(9;22)(q34;q11.2), BCR/ABL1

 

If BCR::ABL1 fusion is not observed, the following probe sets will be performed as a secondary panel:

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

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

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

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

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

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

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

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

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

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

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

 

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 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, request probe AFF1/KMT2A

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

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

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

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

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

 

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

 

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

 

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 set may be performed to identify a potential t(14;18)(q32;q21) or IGH::BCL2 fusion.

Method Name

Fluorescence In Situ Hybridization (FISH)

Reporting Name

B-Lymphoblastic Leuk/Lymph, FISH,Ts

Specimen Type

Tissue

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Tissue 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, 88291-DNA probe, each (first probe set), interpretation and report

88271 x 2-DNA probe, each; each additional probe set (if appropriate)

88271-DNA probe, each; coverage for sets containing 3 probes (if appropriate)

88271 x 2-DNA probe, each; coverage for sets containing 4 probes (if appropriate)

88271 x 3-DNA probe, each; coverage for sets containing 5 probes (if appropriate)

88274 w/modifier 52-Interphase in situ hybridization, <25 cells, each probe set (if appropriate)

88274-Interphase in situ hybridization, 25 to 99 cells, each probe set (if appropriate)

88275-Interphase in situ hybridization, 100 to 300 cells, each probe set (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
BLBLF B-Lymphoblastic Leuk/Lymph, FISH,Ts 102100-5

 

Result ID Test Result Name Result LOINC Value
609452 Result Summary 50397-9
609453 Interpretation 69965-2
609454 Result Table 93356-4
609455 Result 62356-1
GC057 Reason for Referral 42349-1
609456 Specimen 31208-2
609457 Source 31208-2
609458 Tissue ID 80398-1
609459 Method 85069-3
609460 Additional Information 48767-8
609461 Disclaimer 62364-5
609462 Released By 18771-6