Multiple Myeloma (MM) Profile, FISH

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Test Details

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.

Use

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. 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

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

Clinical Information

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, 13q14, 1p/1q, 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.

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
510325 Multiple Myeloma FISH Panel 510768 Specimen Type 31208-2
510325 Multiple Myeloma FISH Panel 510695 Cells Counted 62361-1
510325 Multiple Myeloma FISH Panel 510696 Cells Analyzed 62360-3
510325 Multiple Myeloma FISH Panel 510769 FISH Result 62357-9
510325 Multiple Myeloma FISH Panel 510318 Interpretation 62365-2
510325 Multiple Myeloma FISH Panel 510319 Director Review: 48672-0
510325 Multiple Myeloma FISH Panel 512123 PDF 80563-0

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