Test Id : NGBCL
MayoComplete B-Cell Lymphoma, Next-Generation Sequencing, Varies
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in establishing diagnosis, refining prognosis, and potentially identifying targeted therapies for the optimal management of patients with B-cell lymphomas
Genetics Test Information
Provides information that may help with selection of the correct genetic test or proper submission of the test request
This test includes next-generation sequencing to evaluate the following 46 genes and select intronic regions: ARAF, ARID1A, ATM, B2M, BCL2, BIRC3, BRAF, BTG1, BTK, CARD11, CCND1, CCND3, CD79A, CD79B, CDKN2A, CREBBP, CSF1R, CXCR4, DDX3X, EP300, EZH2, FBXW7, FOXO1, ID3, KLF2, KMT2D, KRAS, MAP2K1, MEF2B, MYD88, NOTCH1, NOTCH2, NRAS, NSD2, PIK3CA, PIM1, PLCG2, PRDM1, PTEN, SF3B1, STAT6, TCF3, TNFAIP3, TNFRSF14, TP53, and XPO1
Highlights
This test utilizes next-generation sequencing for the detection of somatic mutations with diagnostic, prognostic, or therapeutic value in a set of genes associated with low-grade and aggressive B-cell non-Hodgkin lymphomas.
Method Name
A short description of the method used to perform the test
Next-Generation Sequencing (NGS)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
B-cell lymphoma
BCL2
BRAF
BTK
CDKN2A
CXCR4
EZH2
ID3
KLF2
KRAS
MAP2K1
MYD88
Next gen sequencing of lymphoma
Next Gen Sequencing Test
NGBCL
NGS lymphoid malignancies
Non-Hodgkin lymphomas
NOTCH1
NRAS
PLCG2
SF3B1
Somatic mutation detection by next generation sequencing (NGS), lymphoma
TP53
Mayo Complete
.
Specimen Type
Describes the specimen type validated for testing
Varies
Shipping Instructions
Whole blood, bone marrow aspirate, and body fluid specimens must arrive within 14 days of collection.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| MP068 | Specimen Type |
Peripheral blood Bone marrow Paraffin Embedded Tissue Extracted DNA from peripheral blood Extracted DNA from bone marrow Frozen tissue Tissue slides Body Fluid |
| MP069 | Indication for Test |
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:
Specimen Type: Bone marrow aspirate
Container/Tube:
Preferred: Lavender or pink top (EDTA) or yellow top (ACD)
Acceptable: Green top (sodium heparin)
Specimen Volume: 2 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send bone marrow specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Specimen Stability Information: Ambient (preferred) 14 days/Refrigerate 14 days
Additional Information: To ensure minimum volume and concentration of DNA is met, the requested volume must be submitted. Testing may be canceled if DNA requirements are inadequate.
Specimen Type: Whole blood
Container/Tube:
Preferred: Lavender or pink top (EDTA) or yellow top (ACD)
Acceptable: Green top (sodium heparin)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
3. Label specimen as blood.
Specimen Stability Information: Ambient (preferred) 14 days/Refrigerate 14 days
Additional Information: To ensure minimum volume and concentration of DNA is met, the requested volume must be submitted. Testing may be canceled if DNA requirements are inadequate.
Specimen Type: Paraffin-embedded tissue
Container/ Tube: Paraffin block
Collection Instructions:
1. If available, send 1 representative hematoxylin and eosin-stained slide.
2. Minimum amount of tumor nuclei is 20%
3. Required amount of tissue area is at least 25 mm(2)
4. Tissue should be fixed in 10% neutral-buffered formalin. Other fixatives are not acceptable.
5. Decalcified specimens (eg, bone marrow core biopsies) are not acceptable.
Specimen Stability Information: Ambient
Additional Information: If the quality of the biopsy specimen is poor or the target tumor cell population is below 20%, testing should not be ordered. Testing may be canceled if DNA requirements are inadequate.
Specimen Type: Tissue slide
Slides: 10 unstained slides
Container/ Tube: Transport in plastic slide holders.
Collection Instructions:
1. Send 10 unstained, nonbaked slides with 5-micron thick sections of tissue.
2. If available, also send 1 representative hematoxylin and eosin-stained slide.
3. Minimum amount of tumor nuclei is 20%
4. Required amount of tissue area is at least 25 mm(2)
5. Tissue should be fixed in 10% neutral-buffered formalin. Other fixatives are not acceptable.
6. Decalcified specimens (eg, bone marrow core biopsies) are not acceptable.
Specimen Stability Information: Ambient
Additional Information: Testing may be canceled if resultant extracted DNA does not meet concentration requirements.
Specimen Type: Frozen tissue
Container/Tube: Plastic container
Specimen Volume: 100 mg
Collection Instructions: Freeze tissue within 1 hour of collection
Specimen Stability Information: Frozen
Additional Information: Testing may be canceled if resultant extracted DNA does not meet concentration requirements.
Specimen Type: Body fluid
Container/Tube: Sterile container
Specimen Volume: 5 mL
Collection Instructions: Specify the type of fluid being submitted.
Specimen Stability Information: Refrigerated 14 days/Frozen 14 days
Additional Information: Testing may be canceled if resultant extracted DNA does not meet concentration requirements.
Specimen Type: Extracted DNA
Container/Tube: 1.5- to 2-mL tube
Specimen Volume: Entire specimen
Collection Instructions:
1. DNA must be extracted within 14 days after collection.
2. Label specimen as extracted DNA and source of specimen.
3. Indicate volume and concentration of DNA on label.
Specimen Stability Information: Frozen (preferred)/Refrigerated/Ambient
Additional Information: DNA must be extracted in a CLIA-certified laboratory or equivalent and must be extracted from a specimen type listed as acceptable for this test (including applicable anticoagulants). We cannot guarantee that all extraction methods are compatible with this test. If testing fails, one repeat will be attempted, and if unsuccessful, the test will be reported as failed and a charge will be applied.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Forms
1. Hematopathology Patient Information (T676)
2. 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. The minimum volume is sufficient for one attempt at testing.
Whole blood, bone marrow aspirate, body fluid: 1 mL; Frozen tissue: 50 mg; Extracted DNA: 100 microliters (mcL) at 20 ng/mcL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Specimens that have been decalcified (all methods) Bone marrow core biopsies Paraffin shavings Fixatives other than 10% neutral-buffered formalin for paraffin-embedded tissue Moderately to severely clotted bone marrow aspirate | Reject |
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 | Varies | 14 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aiding in establishing diagnosis, refining prognosis, and potentially identifying targeted therapies for the optimal management of patients with B-cell lymphomas
Genetics Test Information
Provides information that may help with selection of the correct genetic test or proper submission of the test request
This test includes next-generation sequencing to evaluate the following 46 genes and select intronic regions: ARAF, ARID1A, ATM, B2M, BCL2, BIRC3, BRAF, BTG1, BTK, CARD11, CCND1, CCND3, CD79A, CD79B, CDKN2A, CREBBP, CSF1R, CXCR4, DDX3X, EP300, EZH2, FBXW7, FOXO1, ID3, KLF2, KMT2D, KRAS, MAP2K1, MEF2B, MYD88, NOTCH1, NOTCH2, NRAS, NSD2, PIK3CA, PIM1, PLCG2, PRDM1, PTEN, SF3B1, STAT6, TCF3, TNFAIP3, TNFRSF14, TP53, and XPO1
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
B-cell lymphomas are a heterogenous group of hematological malignancies characterized by a range of morphological, immunophenotypic, and clinical features. Many entities share overlapping morphologic and immunophenotypic features resulting in challenges for accurate diagnosis and classification. Genomic profiling by next-generation sequencing has revealed many genetic markers that aid in the classification and characterization of mature B-cell neoplasms. In some lymphomas, specific tumor genetic mutations may also have therapeutic implications. This test is intended to interrogate a set of genes with diagnostic, prognostic, and therapeutic value among a diverse group of B-cell lymphomas that include both clinically low grade and aggressive subtypes.
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
Genomic variants detected by this test will be documented in a detailed laboratory-issued report. This report will contain information regarding the detected alterations and their associations with prognosis or possible therapeutic implications in B-cell non-Hodgkin lymphomas. The information in the clinical report may be used by the patient's healthcare professional to help guide decisions concerning management. Final interpretation of next-generation sequencing results requires correlation with all relevant clinical, pathologic, and laboratory findings and is the responsibility of the managing healthcare professional.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is a targeted next-generation sequencing (NGS) panel assay that encompasses 46 genes with variable full exon, partial region (including select intronic or noncoding regions), or hot spot coverage (depending on specific genetic locus). Therefore, this test will not detect other genetic abnormalities in genes or regions outside the specified target areas. The test detects single-base substitutions (ie, point mutations) as well as small insertion or deletion type events. This test is not configured to detect structural genomic rearrangements (ie, translocations), gene fusions, copy number alterations, or large-scale (segmental chromosome region) deletions and other complex genomic changes.
This assay does not distinguish between somatic mutations and germline alterations in analyzed gene regions, particularly with variant allele frequencies near 50% or 100%. If nucleotide alterations in genes associated with germline variant syndromes are present and there is a strong clinical suspicion or family history of malignant disease predisposition, additional genetic testing and appropriate counseling may be indicated. Some apparent mutations classified as variants of undetermined significance may represent rare or low population frequency polymorphisms.
Prior treatment for hematologic malignancy could affect the results obtained in this assay. Particularly, a prior allogeneic hematopoietic stem cell transplant may cause difficulties in either resolving somatic or polymorphic alterations or assigning variant calls correctly to donor and recipient fractions, if pertinent clinical or laboratory information (eg, chimerism engraftment status) is not provided.
Inadequate samples (eg, insufficient DNA quantity or quality) will preclude further testing and will be noted in the interpretive report. For formalin-fixed, paraffin-embedded specimens, NGS testing should not be pursued if the quality of the biopsy specimen is poor (eg, limited sample size, presence of extensive necrosis or fibrosis), or the target tumor cell population is low (<20%).
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Swerdlow S, Campo E, Harris NL, et al, eds. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. IARC Press; 2017. WHO Classification of Tumours, Vol 2
2. Onaindia A, Medeiros LJ, Patel KP. Clinical utility of recently identified diagnostic, prognostic, and predictive molecular biomarkers in mature B-cell neoplasms. Mod Pathol. 2017;30(10):1338-1366. doi:10.1038/modpathol.2017.58
3. Jajosky AA, Havens NP, Sadri N, et al. Clinical utility of targeted next-generation sequencing in the evaluation of low-grade lymphoproliferative disorders. Am J Clin Pathol. 2021;156(3):433-444
4. David AR, Stone SL, Oran AR, et al. Targeted massively parallel sequencing of mature lymphoid neoplasms: assessment of empirical application and diagnostic utility in routine clinical practice. Mod Pathol. 2021;34(5):904-921
5. Stewart JP, Gazdovz J, Darzentas N, et al. Validation of the EuroClonality-NGS DNA capture panel as an integrated genomic tool for lymphoproliferative disorders. Blood Adv. 2021;5(16):3188-3198
6. Treon SP, Cao Y, Xu L, Yang G, Liu X, Hunter ZR. Somatic mutations in MYD88 and CXCR4 are determinants of clinical presentation and overall survival in Waldenstrom macroglobulinemia. Blood. 2014;123(18):2791-2796. doi:10.1182/blood-2014-01-550905
7. Morin RD, Arthur SE, Assouline S. Treating lymphoma is now a bit EZ-er. Blood Adv. 2021;5(8):2256-2263
8. Thangavadivel S, Byrd JC. Gly101Val BCL2 mutation: One step closer to understanding Venetoclax resistance in CLL. Cancer Discov. 2019;9(3):320-322. doi:10.1158/2159-8290.CD-19-0029
9. Lee J, Wang YL. Prognostic and predictive molecular biomarkers in chronic lymphocytic leukemia. J Mol Diagn. 2020;22(9):1114-1125
10. Liebers N, Roider T, Bohn J-P, et al. BRAF inhibitor treatment in classic hairy cell leukemia: a long-term follow-up study of patients treated outside clinical trials. Leukemia. 2020;34(5):1454-1457
Method Description
Describes how the test is performed and provides a method-specific reference
This is a target-enriched next-generation sequencing (NGS) panel. DNA is extracted from validated specimen sources including but not limited to peripheral blood, bone marrow aspirate, and formalin-fixed paraffin embedded tissues. Library preparation for NGS is performed followed by probe hybridization and capture. Sequencing of the final sample library is performed on a NGS instrument. Following bioinformatic processing of the sequencing data, the sequencing results are interpreted to provide a final clinical report. Genomic alterations are called according to human genome reference build GRCh37 (hg19).(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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 account representative. 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. It 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.
CPT codes are provided by the performing laboratory.
81450
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 |
|---|---|---|
| NGBCL | B-cell Lymphoma, NGS, V | 104239-9 |
| 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.
|
|---|---|---|
| MP068 | Specimen Type | 31208-2 |
| MP069 | Indication for Test | 42349-1 |
| 618495 | NGBCL Result | No LOINC Needed |
| 618496 | Pathogenic Mutations Detected | 82939-0 |
| 618497 | Interpretation | 69047-9 |
| 618499 | Variants of Unknown Significance | 93367-1 |
| 618500 | Additional Information | 48767-8 |
| 618498 | Clinical Trials | 82786-5 |
| 618501 | Method Summary | 85069-3 |
| 618502 | Disclaimer | 62364-5 |
| 618503 | Panel Gene List | 36908-2 |
| 618504 | Reviewed By | 18771-6 |