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Test Code NGCLN MayoComplete Chronic Lymphoid Neoplasms, Next-Generation Sequencing, Varies


Shipping Instructions


Whole blood, bone marrow aspirate, and body fluid specimens must arrive within 14 days of collection.



Specimen Required


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

 

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 peripheral blood.

2. Send whole blood specimen in original tube. Do not aliquot.

3. Label specimen as peripheral blood.

Specimen Stability Information: Ambient (preferred) 14 days/Refrigerate

 

Specimen Type: Paraffin-embedded tissue

Container/ Tube: Paraffin block

Collection Instructions:

1. Send 1 representative slide stained with hematoxylin and eosin

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

 

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 and 1 representative slide stained with hematoxylin and eosin.

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

 

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 

 

Specimen Type: Body fluid

Container/Tube: Sterile container

Specimen Volume: 5 mL

Specimen Stability Information: Refrigerated 14 days/Frozen

 

Specimen Type: Extracted DNA

Container/Tube: 1.5- to 2-mL tube

Specimen Volume: Entire specimen

Collection Instructions:

1. Label specimen as extracted DNA and source of specimen.

2. Indicate volume and concentration of DNA on label.

Specimen Stability Information: Frozen (preferred)/Refrigerated/Ambient


Secondary ID

618476

Useful For

Aiding in establishing diagnosis, refining prognosis, and potentially identifying targeted therapies for the optimal management of patients with chronic or low-grade B-cell lymphoid neoplasms

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 chronic or clinically "low grade" lymphoid neoplasms.

Method Name

Next-Generation Sequencing (NGS)

Reporting Name

Chronic Lymphoid Neoplasms, NGS, V

Specimen Type

Varies

Specimen Minimum Volume

Whole blood, bone marrow aspirate, body fluid: 1 mL; Frozen tissue: 50 mg; Extracted DNA: 100 microliters (mcL) at 20 ng/mcL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies 14 days

Reject Due To

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

Clinical Information

This test is intended to evaluate a targeted set of genes involved in a heterogeneous group of chronic lymphoid neoplasms that includes chronic lymphocytic leukemia (CLL) and various low-grade B-cell lymphomas. The test includes actionable targets to aid in the differential diagnosis of low-grade B-cell lymphomas (eg, hairy cell leukemia, lymphoplasmacytic lymphoma, splenic marginal zone lymphoma), predict prognosis (eg, risk stratification in CLL), and evaluate therapeutic options or efficacy (eg, ibrutinib therapy in CLL, EZH2 [enhancer of zeste homolog 2] inhibitors in follicular lymphoma). Genomic analysis by next-generation sequencing is complementary to the standard evaluation in the classification and management of patients with chronic lymphoid neoplasms.

Reference Values

An interpretive report will be provided.

Interpretation

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 chronic lymphoid neoplasms. The information in the clinical report may be used by the patient’s clinician 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 clinician.

Method Description

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)

Day(s) Performed

Monday through Friday

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

81450

LOINC Code Information

Test ID Test Order Name Order LOINC Value
NGCLN Chronic Lymphoid Neoplasms, NGS, V 104238-1

 

Result ID Test Result Name Result LOINC Value
MP065 Specimen Type 31208-2
MP066 Indication for Test 42349-1
618485 NGCLN Result No LOINC Needed
618486 Pathogenic Mutations Detected 82939-0
618487 Interpretation 69047-9
618489 Variants of Unknown Significance 93367-1
618490 Additional Information 48767-8
618488 Clinical Trials 82786-5
618491 Method Summary 85069-3
618492 Disclaimer 62364-5
618493 Panel Gene List 36908-2
618494 Reviewed By 18771-6