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Test Code NGPCM MayoComplete Plasma Cell Myeloma, Next-Generation Sequencing, Varies


Shipping Instructions


Bone marrow aspirate samples must arrive within 4 days of collection.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Bone marrow aspirate

Container/Tube: Lavender or pink top (EDTA) or yellow top (ACD)

Specimen Volume: 2 mL

Collection Instructions:

1. Minimum plasma cell percentage is 5%.

2. Invert several times to mix bone marrow.

3. Send bone marrow specimen in original tube. Do not aliquot.

4. Label specimen as bone marrow.

5. Fresh specimen is required for this test, as testing is performed on sorted cells.

Specimen Stability Information: Ambient (preferred) 4 days/Refrigerate

 

Specimen Type: Paraffin-embedded bone marrow clot

Container/Tube: Paraffin block

Collection Instructions:

1. Send 1 slide stained with hematoxylin and eosin.

2. Minimum plasma cell percentage is 20%.

3. Required amount of tissue area is at least 25mm(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; bone marrow clot

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 slide stained with hematoxylin and eosin

2. Minimum amount of plasma cells is 20%

3. Required amount of tissue area is at least 25mm(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 


Forms

1. Hematopathology Patient Information (T676)

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

Secondary ID

618479

Useful For

Evaluating multiple myeloma at the time of diagnosis and at disease relapse or when changing clinical management to provide prognostic information and determine potential therapeutic implications

Highlights

Next-generation sequencing detection of somatic gene variations in plasma cell myeloma may have prognostic and potential therapeutic implications. This test is appropriate for diagnosis and disease relapse.

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
CSPMM NGPCM Pre-Analysis Cell Sorting, BM No No

Testing Algorithm

See Targeted Genes Interrogated by MayoComplete Plasma Cell Myeloma Next-Generation Sequencing for a list of the genes and exons targeted by this assay.

Method Name

Next-Generation Sequencing (NGS)

Reporting Name

Plasma Cell Myeloma, NGS, V

Specimen Type

Varies

Specimen Minimum Volume

Bone marrow aspirate: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Varies

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Specimens that have been decalcified (all methods)
Bone marrow core biopsies
Paraffin shavings
Frozen tissue
Extracted DNA
Moderately to severely clotted bone marrow aspirate		 Reject

Clinical Information

Multiple myeloma (MM) is a malignancy of bone marrow plasma cells with an annual global incidence of nearly 200,000. Comprehensive clinical, radiologic, and laboratory evaluation can initially stratify patients by disease phase and burden. Cytogenetic and fluorescence in situ hybridization studies are important to help classify MM into standard, intermediate, and high-risk groups. Advances in nontargeted therapies, including autologous bone marrow transplantation, have significantly improved the outcome of many patients; however, most patients with myeloma suffer relapse after initial treatment. Clinical next-generation sequencing (NGS) technology has enabled a deeper and more detailed evaluation of MM genetics. Testing allows for further risk categorization of the disease through the identification of additional genetic abnormalities of prognostic and potentially therapeutic value. Application of targeted NGS-based analysis is a useful adjunct to the standard evaluation of MM patients at diagnosis and relapse. This test comprises a DNA-based multigene panel that includes preanalytic plasma cell enrichment, NGS, and detailed analysis, resulting in a clinical report.

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 plasma cell myeloma. 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 laboratory-developed target enriched next generation sequencing (NGS) panel. DNA is extracted from validated specimen sources including bone marrow aspirate and formalin-fixed paraffin embedded tissues (eg, bone marrow clot). Bone marrow aspirate specimens are enriched for plasma cells sorted by a flow cytometric cell selection method prior to DNA extraction. 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
NGPCM Plasma Cell Myeloma, NGS, V 104241-5

 

Result ID Test Result Name Result LOINC Value
MP074 Specimen Type 31208-2
MP075 Indication for Test 42349-1
618515 NGPCM Result No LOINC Needed
618516 Pathogenic Mutations Detected 82939-0
618517 Interpretation 69047-9
618519 Variants of Unknown Significance 93367-1
618520 Additional Information 48767-8
618518 Clinical Trials 82786-5
618521 Method Summary 85069-3
618522 Disclaimer 62364-5
618523 Panel Gene List 36908-2
618524 Reviewed By 18771-6