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CPT:
Contact CPT coding department at 800-222-7566, ext 6-8400.
Synonyms
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Plasma Cell Leukemia
Test Includes
Fluorescence in situ hybridization (FISH) for multiple myeloma (MM), targeting 13q14, IGH/CCND1, TP53, FGFR1/IGH, cMAF/IGH, amplification of 1p/1q, on plasma enriched cells.
Special Instructions
Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form. If insufficient plasma cells are available, the following probe priority will be followed: Previous abnormality, p53, FGFR3/IGH, MAF/IGH, 1p/1q, 13q14, CCND1/IGH, 7/9/15 aneuploidy probes. If a chromosome study (510999) is ordered concurrently and sample is not sufficient for both tests, FISH will be prioritized.
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Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form. If insufficient plasma cells are available, the following probe priority will be followed: Previous abnormality, p53, FGFR3/IGH, MAF/IGH, 1 |
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Indicate pertinent clinical diagnosis and previous cytogenetics studies on the test request form. If insufficient plasma cells are available, the following probe priority will be followed: Previous abnormality, p53, FGFR3/IGH, MAF/IGH, 1p/1q, 13q14, CCND1/IGH, 7/9/15 aneuploidy probes. If a chromosome study (510999) is ordered concurrently and sample is not sufficient for both tests, FISH will be prioritized. |
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
Specimen Requirements
Specimen
Bone marrow
Volume
1 to 3 mL bone marrow
Minimum Volume
1 mL bone marrow
Container
Green-top (sodium heparin) tube with bone marrow aspirate
Collection
Transport to the testing lab at room temperature; use a cool pack or LabCorp transport kit. Do not allow sample to freeze. Sample must arrive in the laboratory within 72 hours of collection.
Storage Instructions
Maintain specimen at room temperature.
Causes for Rejection
Whole blood; broken Vacutainer®; specimen received at testing facility 72 hours after collection
Test Details
Use
This is a diagnostic test for multiple myeloma. Plasma cell enrichment diagnosis increased as much as 50% to 100%. The FISH results on the enriched assay should not be used as a quantitative assay, since the abnormal cells do not represent the percentage of abnormal cells in the aspirate.
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This is a diagnostic test for multiple myeloma. Plasma cell enrichment diagnosis increased as much as 50% to 100%. The FISH results on the enriched assay should not be used as a quantitative assay, since the abnormal cells do not represent the percentage of abnormal cells in the aspirate. |
Limitations
Molecular mutations below the resolution of FISH will not be detected. This test also will not detect regions not targeted by FISH probes.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
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Molecular mutations below the resolution of FISH will not be detected. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. |
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Molecular mutations below the resolution of FISH will not be detected. This test also will not detect regions not targeted by FISH probes. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. |
Methodology
Fluorescence in situ hybridization (FISH) and plasma cell enrichment
References
Fonseca R, Barlogie B, Bataille R, et al. Genetics and cytogenetics of multiple myeloma: A workshop report. Cancer Res. 2004 Feb 15; 64(4):1546-1558. 14989251
Fonseca R, Bergsagel PL, Drach J, et al. International Myeloma Working Group Molecular Classification of Multiple Myeloma: Spotlight review. Leukemia. 2009 Dec; 23(12):2210-2221. 19798094
Pozdnyakova O, Crowley-Larsen P, Zota V, et al. Interphase FISH in plasma cell dyscrasia: increase in abnormality detection with plasma cell enrichment. Cancer Genet Cytogenet. 2009 Mar; 189(2):112-117. 19215792
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