Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with chronic lymphocytic leukemia (CLL)
Identifying and tracking known chromosome abnormalities in patients with CLL and tracking response to therapy
Distinguishing patients with 11;14 translocations who have leukemic phase of mantle cell lymphoma from patients who have CLL
Detecting patients with atypical CLL or other forms of lymphoma associated with translocations between IGH and BCL3
Test Id | Reporting Name | Available Separately | Always Performed |
---|---|---|---|
CLLDB | Probe, Each Additional (CLLDF) | No, (Bill Only) | No |
This test includes a charge for the probe application, analysis, and professional interpretation of results for 6 probe sets (12 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.
Panel includes testing for the following abnormalities using the probes listed:
6q-, D6Z1/MYB
11q-, D11Z1/ATM
+12, D12Z3/MDM2
13q-, D13S319/LAMP1
17p-, TP53/D17Z1
t(11;14), CCND1/IGH
When an additional IGH signal is identified in the absence of a CCND1/IGH fusion, reflex testing using the IGH/BCL3 probe set will be performed to identify a potential IGH/BCL3 fusion [t(14;19)(q32;q13)].
This assay detects abnormalities observed in the blood and bone marrow of patients with chronic lymphocytic leukemia. If a paraffin-embedded tissue sample is received, this test will be cancelled and SLL / Small Lymphocytic Lymphoma, FISH, Tissue will be added and performed as the appropriate test.
+12
11q- (11q deletion) or ATM
13q- (13q deletion) or LAMP1
17p- (17p deletion) or TP53
6q- (6q deletion) or MYB
t(11;14)(q13;q32) - CCND1/IGH
This test includes a charge for the probe application, analysis, and professional interpretation of results for 6 probe sets (12 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.
Panel includes testing for the following abnormalities using the probes listed:
6q-, D6Z1/MYB
11q-, D11Z1/ATM
+12, D12Z3/MDM2
13q-, D13S319/LAMP1
17p-, TP53/D17Z1
t(11;14), CCND1/IGH
When an additional IGH signal is identified in the absence of a CCND1/IGH fusion, reflex testing using the IGH/BCL3 probe set will be performed to identify a potential IGH/BCL3 fusion [t(14;19)(q32;q13)].
This assay detects abnormalities observed in the blood and bone marrow of patients with chronic lymphocytic leukemia. If a paraffin-embedded tissue sample is received, this test will be cancelled and SLL / Small Lymphocytic Lymphoma, FISH, Tissue will be added and performed as the appropriate test.
Varies
If testing a paraffin-embedded tissue specimen for patients with chronic lymphocytic leukemia (CLL) is desired, order SLL / Small Lymphocytic Lymphoma, FISH, Tissue.
Advise Express Mail or equivalent if not on courier service.
1. Provide a reason for testing 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.
2. A pathology and/or flow cytometry report may be requested by the Genomics Laboratory to optimize testing and aid in interpretation of results.
Question ID | Description | Answers |
---|---|---|
GC088 | Reason for Referral | |
GC089 | Specimen |
Whole Blood ACD Bone Marrow ACD Whole Blood Na Hep Bone Marrow Na Hep Whole Blood EDTA Bone Marrow EDTA |
Submit only 1 of the following specimens:
Specimen Type: Blood
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (sodium heparin), purple top (EDTA)
Specimen Volume: 6 mL
Collection Instructions: Invert several times to mix blood.
Specimen Type: Bone marrow
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (sodium heparin), purple top (EDTA)
Specimen Volume: 1-2 mL
Collection Instructions: Invert several times to mix bone marrow.
If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.
Blood: 2 mL
Bone Marrow: 1 mL
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Ambient (preferred) | ||
Refrigerated |
Detecting a neoplastic clone associated with the common chromosome abnormalities seen in patients with chronic lymphocytic leukemia (CLL)
Identifying and tracking known chromosome abnormalities in patients with CLL and tracking response to therapy
Distinguishing patients with 11;14 translocations who have leukemic phase of mantle cell lymphoma from patients who have CLL
Detecting patients with atypical CLL or other forms of lymphoma associated with translocations between IGH and BCL3
This test includes a charge for the probe application, analysis, and professional interpretation of results for 6 probe sets (12 individual fluorescence in situ hybridization probes). Additional charges will be incurred for all reflex or additional probe sets performed.
Panel includes testing for the following abnormalities using the probes listed:
6q-, D6Z1/MYB
11q-, D11Z1/ATM
+12, D12Z3/MDM2
13q-, D13S319/LAMP1
17p-, TP53/D17Z1
t(11;14), CCND1/IGH
When an additional IGH signal is identified in the absence of a CCND1/IGH fusion, reflex testing using the IGH/BCL3 probe set will be performed to identify a potential IGH/BCL3 fusion [t(14;19)(q32;q13)].
This assay detects abnormalities observed in the blood and bone marrow of patients with chronic lymphocytic leukemia. If a paraffin-embedded tissue sample is received, this test will be cancelled and SLL / Small Lymphocytic Lymphoma, FISH, Tissue will be added and performed as the appropriate test.
Chronic lymphocytic leukemia (CLL) is the most common leukemia in North America. The most common cytogenetic abnormalities in CLL involve chromosomes 6, 11, 12, 13 and 17. These are detected and quantified using the CLL fluorescence in situ hybridization (FISH) panel.
Use of CpG-oligonucleotide mitogen will identify an abnormal CLL karyotype in at least 80% of cases. This mitogen is added to cultures when chromosome analysis is ordered and the reason for referral is a B-cell disorder (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow and CHRHB / Chromosome Analysis, Hematologic Disorders, Blood).
This FISH test detects an abnormal clone in approximately 70% of patients with indolent disease and in greater than 80% of patients who require treatment. At least 5% of patients referred for CLL FISH testing have translocations involving the IGH locus. Fusion of IGH with CCND1 is associated with t(11;14)(q13;q32), and fusion of IGH with BCL3 is associated with t(14;19)(q32;q13.3). Patients with t(11;14) usually have the leukemic phase of mantle cell lymphoma. Patients with t(14;19) may have an atypical form of B-CLL or the leukemic phase of a lymphoma.
The prognostic associations for chromosome abnormalities detected by this FISH assay are, from best to worst: 13q-, normal, +12, 6q-, 11q- and 17p-.
An interpretive report will be provided.
A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe set.
The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.
This test is not approved by the U.S. Food and Drug Administration and it is best used as an adjunct to existing clinical and pathologic information.
Each probe was independently tested and verified on unstimulated peripheral blood and bone marrow specimens. Normal cutoffs were calculated based on the results of at least 25 normal specimens. For each probe set a series of chromosomally abnormal specimens were evaluated to confirm each probe set detected the abnormality it was designed to detect.
1. Dewald GW, Brockman SR, Paternoster SF, et al: Chromosome anomalies detected by interphase FISH: correlation with significant biological features of B-cell chronic lymphocytic leukemia. Br J Haematol. 2003;121:287-295
2. Dohner H, Stilgenbauer S, Benner A, et al: Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med. 2000 Dec;343(26):1910-1916
3. Van Dyke DL, Shanafelt TD, Call TG, et al: A comprehensive evaluation of the prognostic significance of 13q deletions in patients with B-chronic lymphocytic leukaemia. Br J Haematol. 2010;148:544-550
4. Shanafelt TD: Predicting clinical outcome in CLL: how and why. Hematology Am Soc Hematol Educ Program. 2009;421-429
5. Van Dyke DL, Werner L, Rassenti LZ, et al: The Dohner fluorescence in situ hybridization prognostic classification of chronic lymphocytic leukaemia (CLL): the CLL Research Consortium experience. Br J Haematol. 2016 Apr;173(1):105-113
This test is performed using commercially available and laboratory-developed probes. Deletion of chromosomes 6q, 11q, 13q and 17p, and trisomy of chromosome 12 are detected using enumeration strategy probes. A dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe set is used to detect CCND1/IGH rearrangements and for reflex testing to identify IGH/BCL3 rearrangements. For enumeration strategy probe sets, 100 interphase nuclei are scored; 200 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.(Unpublished Mayo method)
Monday through Friday
This test was developed using an analyte specific reagent. Its performance characteristics were 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.
88271 x 12
88275 x 6
88291 - FISH Probe, Analysis, Interpretation; 6 probe sets
88271 x 2 (if appropriate)
88275 x1 - FISH Probe, Analysis; each additional probe set (if appropriate)
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
CLLDF | CLL, Diagnostic FISH | In Process |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
610714 | Result Summary | 50397-9 |
610715 | Interpretation | 69965-2 |
610716 | Result Table | 93356-4 |
610717 | Result | 62356-1 |
GC088 | Reason for Referral | 42349-1 |
GC089 | Specimen | 31208-2 |
610718 | Source | 85298-8 |
610719 | Method | 85069-3 |
610720 | Additional Information | 48767-8 |
610721 | Disclaimer | 62364-5 |
610722 | Released by | 18771-6 |
Change Type | Effective Date |
---|---|
Test Status - Test Resumed | 2022-07-21 |
Test Status - Test Down | 2021-06-25 |