Test Catalog

Test Id : TALMF

T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements observed in patients with T-cell acute lymphoblastic leukemia (T-ALL) using client specified probes

 

An adjunct to conventional chromosome studies in patients with T-ALL

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

 

Identifying and tracking known chromosome abnormalities in patients with T-ALL and monitoring response to therapy

Reflex Tests
Lists tests that may or may not be performed, at an additional charge, depending on the result and interpretation of the initial tests.

Test Id Reporting Name Available Separately Always Performed
TALMB Probe, Each Additional (TALMF) No, (Bill Only) No

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test includes a charge for the probe application, analysis, and professional interpretation of results for 1 probe set (2 individual fluorescence in situ hybridization (FISH) probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

If the patient is being treated for known abnormalities, indicate the abnormality and which probes should be used.

 

When specified, any of the following probes will be performed:

1p33 rearrangement, TAL1/STIL

t(5;14), TLX3/BCL11B

5q32 rearrangement, PDGFRB break-apart

7q34 rearrangement, TRB break-apart

t(6;7)(q23;q34) MYB/TRB

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

+9/9p-, CDKN2A/D9Z1

9p24.1 rearrangement, JAK2 break-apart

t(9;22) or ABL1 amplification, ABL1/BCR

9q34 rearrangement, ABL1 break-apart

t(10;11), MLLT10/PICALM

11q23 rearrangement, MLL (KMT2A) break-apart

t(4;11)(q21;q23) AFF1/MLL

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(9;11)(p22;q23) MLLT3/MLL

t(10;11)(p12;q23) MLLT10/MLL

t(11;19)(q23;p13.1) MLL/ELL

t(11;19)(q23;p13.3) MLL/MLLT1

14q11.2 rearrangement, TRAD break-apart

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1/TRAD

t(11;14)(p15;q11.2) LMO1/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

-17/17p-, TP53/D17Z1

Method Name
A short description of the method used to perform the test

Fluorescence In Situ Hybridization (FISH)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

ALL (T-cell), Specified FISH

Aliases
Lists additional common names for a test, as an aid in searching

(9p24.1;var) - JAK2 rearrangement

9p- (9p deletion) or CDKN2A or p16

t(9;22)(q34;q11.2) - BCR/ABL1

MLL or KMT2A (11q23) rearrangement

t(4;11)(q21;q23) - AFF1/MLL or AFF4/MLL

t(6;11)(q27;q23) - MLLT4/MLL or AF6/MLL

t(9;11)(p22;q23) - MLLT3/MLL or AF9/MLL

t(10;11)(p13;q23) - MLLT10/MLL

t(11;19)(q23;p13.3) - MLL/MLLT1 or MLL/ENL

t(11;19)(q23;p13.1) - MLL/ELL

17p- (17p deletion) or TP53

t(5;14)(q35;q32) - TLX3/BCL11B or HOX11L2/BCL11B

T-cell receptor beta (TRB) (7q34) rearrangement

t(6;7)(q23;q34) MYB/TRB

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

T-cell receptor alpha/delta (TRAD) (14q11.2) rearrangement

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1/TRAD

t(11;14)(p15;q11.2) LMO1/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

t(10;11)(p13;q14) - MLLT10/PICALM or AF10/PICALM

TAL1/STIL (1p33) rearrangement or TAL/SIL

t(9q34;var) - ABL1 rearrangement

t(5q32;var) - PDGFRB rearrangement

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test includes a charge for the probe application, analysis, and professional interpretation of results for 1 probe set (2 individual fluorescence in situ hybridization (FISH) probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

If the patient is being treated for known abnormalities, indicate the abnormality and which probes should be used.

 

When specified, any of the following probes will be performed:

1p33 rearrangement, TAL1/STIL

t(5;14), TLX3/BCL11B

5q32 rearrangement, PDGFRB break-apart

7q34 rearrangement, TRB break-apart

t(6;7)(q23;q34) MYB/TRB

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

+9/9p-, CDKN2A/D9Z1

9p24.1 rearrangement, JAK2 break-apart

t(9;22) or ABL1 amplification, ABL1/BCR

9q34 rearrangement, ABL1 break-apart

t(10;11), MLLT10/PICALM

11q23 rearrangement, MLL (KMT2A) break-apart

t(4;11)(q21;q23) AFF1/MLL

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(9;11)(p22;q23) MLLT3/MLL

t(10;11)(p12;q23) MLLT10/MLL

t(11;19)(q23;p13.1) MLL/ELL

t(11;19)(q23;p13.3) MLL/MLLT1

14q11.2 rearrangement, TRAD break-apart

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1/TRAD

t(11;14)(p15;q11.2) LMO1/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

-17/17p-, TP53/D17Z1

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

This test is intended for instances when limited T-cell acute lymphoblastic leukemia (ALL) fluorescence in situ hybridization (FISH) probes are needed. The FISH probes to be analyzed must be specified on the request, otherwise test processing may be delayed in order to determine intended analysis.

-For an adult patient, if the entire T-cell ALL FISH panel is preferred, order TALAF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies.

-For a pediatric patient, if the entire T-cell ALL FISH panel is desired, order TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric, 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 COGTF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies.

 

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.

 

At diagnosis, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and a complete TALAF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Adult, Varies or TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric, Varies should be performed, depending on patient's age.

 

For patients with T-cell lymphoma, order TLPDF / T-Cell Lymphoma, Diagnostic FISH, Varies.

 

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

Shipping Instructions

Advise Express Mail or equivalent if not on courier service.

Necessary Information

1. A list of probes requested for analysis is required. Probes available for this test are listed in the Testing Algorithm section.

2. A reason for testing and 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; however, appropriate testing and/or interpretation may be compromised or delayed in some instances. If not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
GC134 Reason for Referral
GC135 Probes Requested
GC136 Specimen Whole blood ACD
Bone marrow ACD

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Submit only 1 of the following specimens:

 

Preferred

Specimen Type: Bone marrow

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (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: Blood

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (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.

Forms

If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

Blood: 2 mL

Bone Marrow: 1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
Refrigerated

Useful For
Suggests clinical disorders or settings where the test may be helpful

Detecting a neoplastic clone associated with the common chromosome abnormalities and classic rearrangements observed in patients with T-cell acute lymphoblastic leukemia (T-ALL) using client specified probes

 

An adjunct to conventional chromosome studies in patients with T-ALL

 

Evaluating specimens in which standard cytogenetic analysis is unsuccessful

 

Identifying and tracking known chromosome abnormalities in patients with T-ALL and monitoring response to therapy

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

This test includes a charge for the probe application, analysis, and professional interpretation of results for 1 probe set (2 individual fluorescence in situ hybridization (FISH) probes). Additional charges will be incurred for all reflex or additional probe sets performed.

 

If the patient is being treated for known abnormalities, indicate the abnormality and which probes should be used.

 

When specified, any of the following probes will be performed:

1p33 rearrangement, TAL1/STIL

t(5;14), TLX3/BCL11B

5q32 rearrangement, PDGFRB break-apart

7q34 rearrangement, TRB break-apart

t(6;7)(q23;q34) MYB/TRB

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

+9/9p-, CDKN2A/D9Z1

9p24.1 rearrangement, JAK2 break-apart

t(9;22) or ABL1 amplification, ABL1/BCR

9q34 rearrangement, ABL1 break-apart

t(10;11), MLLT10/PICALM

11q23 rearrangement, MLL (KMT2A) break-apart

t(4;11)(q21;q23) AFF1/MLL

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(9;11)(p22;q23) MLLT3/MLL

t(10;11)(p12;q23) MLLT10/MLL

t(11;19)(q23;p13.1) MLL/ELL

t(11;19)(q23;p13.3) MLL/MLLT1

14q11.2 rearrangement, TRAD break-apart

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1/TRAD

t(11;14)(p15;q11.2) LMO1/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

-17/17p-, TP53/D17Z1

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Acute lymphoblastic leukemia (ALL) accounts for approximately 70% of all childhood leukemia cases (ages 0 to 19 years), making it the most common type of childhood cancer.

 

Approximately 85% of pediatric cases of ALL are of B-cell lineage (B-ALL) and 15% are of T-cell lineage (T-ALL). T-ALL is more common in adolescents than younger children and accounts for 25% of adult ALL. When occurring as a primary lymphoblastic lymphoma (LBL), approximately 90% are T-cell lineage versus only 10% B-cell lineage. T-LBL often present as a mediastinal mass in younger patients, with or without concurrent bone marrow involvement.

 

Specific genetic abnormalities are identified in the majority of cases of T-ALL, although many of the classic abnormalities are "cryptic" by conventional chromosome studies and must be identified by fluorescence in situ hybridization (FISH) studies. Each of the genetic subgroups is important to detect and can be critical prognostic markers.

 

A combination of cytogenetic and FISH testing is currently recommended in all pediatric and adult patients to characterize the T-ALL clone for the prognostic genetic subgroups. A summary of the characteristic chromosome abnormalities identified in T-ALL is listed in the following table.

 

Table. Common Chromosome Abnormalities in T-cell Acute Lymphoblastic Leukemia

Cytogenetic change

Genes involved

del(1p33)

TAL1/STIL

t(5;14)(q35;q32)

TLX3/BCL11B

t(5q32;var)

PDGFRB

t(10;11)(p13;q14)

MLLT10/PICALM

Episomal amplification

ABL1

del(9p)

CDKN2A(p16)

t(9p24.1;var)

JAK2

t(9q34;var)

ABL1

t(11q23;var)

MLL(KMT2A)

t(4;11)(q21;q23)

AFF1/MLL(KMT2A)

t(6;11)(q27;q23)

MLLT4(AFDN)/MLL(KMT2A)

t(9;11)(p22;q23)

MLLT3/MLL(KMT2A)

t(10;11)(p13;q23)

MLLT10/MLL(KMT2A)

t(11;19)(q23;p13.1)

MLL(KMT2A)/ELL

t(11;19)(q23;p13.3)

MLL(KMT2A)/MLLT1

t(7q34;var)

TRB

t(6;7)(q23;q34)

MYB/TRB

t(7;10)(q34;q24)

TRB/TLX1

t(7;11)(q34;p15)

TRB/LMO1

t(7;11)(q34;p13)

TRB/LMO2

t(14q11.2;var)

TRAD

t(8;14)(q24.1;q11.2)

MYC/TRAD

t(10;14)(q24;q11.2)

TLX1/TRAD

t(11;14)(p15;q11.2)

LMO1/TRAD

t(11;14)(p13;q11.2)

LMO2/TRAD

del(17p)

TP53

Complex karyotype (> or =4 abnormalities)

 

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided.

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.

 

Bone marrow is the preferred sample type for this fluorescence in situ hybridization test. If bone marrow is not available, a blood specimen may be used if there are neoplastic cells in the blood specimen (as verified by a hematopathologist).

Supportive Data

Each probe was independently tested and verified on unstimulated peripheral blood and bone marrow specimens. Normal cutoffs were calculated based on the results of 25 normal specimens. Each probe set was evaluated to confirm the probe set detected the abnormality it was designed to detect.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Swerdlow SH, Campo E, Harris NL, et al, eds: WHO Classification of Tumours. Vol 2. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. IARC Press; 2017

2. Gesk S, Martin-Subero JI, Harder L, et al: Molecular cytogenetic detection of chromosomal breakpoints in T-cell receptor gene loci. Leukemia. 2003;17:738-745

3. Chin M, Mugishima H, Takamura M, et al: Hemophagocytic syndrome and hepatosplenic (gamma)(delta) T-cell lymphoma with isochromosome 7q and 8 trisomy. J Pediatr Hematol Oncol. 2004;26(6):375-378

4. Graux C, Cools J, Michaux L, Vandenberghe P, Hagemeijer A : Cytogenetics and molecular genetics of T-cell acute lymphoblastic leukemia: from thymocyte to lymphoblast. Leukemia. 2006;20:1496-1510

5. Cayuela JM, Madani A, Sanhes L, Stern MH, Sigaux F: Multiple tumor-suppressor gene 1 inactivation is the most frequent genetic alteration in T-cell acute lymphoblastic leukemia. Blood 1996;87:2180-2186

6. Hayette S, Tigaud I, Maguer-Satta V, et al: Recurrent involvement of the MLL gene in adult T-lineage acute lymphoblastic leukemia. Blood. 2002;99:4647-4649

7. Graux C, Cools J, Melotte C, et al: Fusion of NUP214 to ABL1 on amplified episomes in T-cell acute lymphoblastic leukemia. Nat Genet. 2004;36:1084-1089

Method Description
Describes how the test is performed and provides a method-specific reference

This test is performed using commercially available and laboratory-developed probes. Deletion of the CDKN2A locus on chromosome 9 and TP53 on chromosome 17 are detected using enumeration strategy probes. Rearrangements involving TAL1/STIL, PDGFRB, TRB, JAK2, ABL1, MLL (KMT2A), and TRAD are detected using dual-color break-apart (BAP) strategy probes. Dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe sets are used to detect t(5;14), t(9;22), t(10;11), and in reflex testing when rearrangements of MLL, TRB, or TRAD genes are detected. Amplification of the ABL1 gene region (9q34) is detected using a D-FISH probe strategy. For enumeration and BAP strategy probe sets, 100 interphase nuclei are scored; 200 interphase nuclei are scored when D-FISH probes are used. All results are expressed as the percent abnormal nuclei.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

7 to 10 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

4 weeks

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics 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.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

88271x2, 88275x1, 88291x1-FISH Probe, Analysis, Interpretation; 1 probe set

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

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
TALMF ALL (T-cell), Specified 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.
614325 Result Summary 50397-9
614326 Interpretation 69965-2
614327 Result Table 93356-4
614328 Result 62356-1
GC134 Reason for Referral 42349-1
GC135 Probes Requested 78040-3
GC136 Specimen 31208-2
614329 Source 31208-2
614330 Method 85069-3
614331 Additional Information 48767-8
614332 Disclaimer 62364-5
614333 Released By 18771-6

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports