Fluorescence in situ Hybridization (FISH)
Companion test:
Fluorescence in situ Hybridization (FISH)
Use to monitor for a previously identified clone.
Multiple myeloma (MM) is a plasma cell dyscrasia that can evolve from a premalignant monoclonal gammopathy. Prognosis often depends on the presence or absence of particular genetic markers. Bone marrow aspirate and biopsy with fluorescence in situ hybridization (FISH) testing for relevant markers should be performed as clinically indicated, including upon diagnosis and in low-/standard-risk individuals at time of relapse to aid in risk stratification. ,
Test Description
This test involves the performance of FISH on CD138+ enriched cells (assuming the specimen is sufficient for enrichment) for multiple myeloma prognosis-specific genomic abnormalities:
- 1p (CDKN2C loss/deletion)/1q (CKS1B gain/amplification)
- 17p (TP53 loss/deletion)/17q (NF1) control
- t(4;14) (IGH/FGFR3 or NSD2 [MMSET] fusion)
- t(11;14) (IGH/CCND1 fusion and/or +11)
- t(14;16) (IGH/MAF fusion)
- t(14;20) (IGH/MAFB fusion)
Disease Overview
Age of Onset
Most frequently diagnosed between ages 65 and 74 years (median age 69 years)
Symptoms
Presenting clinical features include symptoms of , :
- Hypercalcemia
- Impaired renal function
- Anemia
- Bone disease (lesions)
Clinical Implications of Tested Genomic Abnormalities
Abnormalities are detected by conventional cytogenetics in approximately 30% of MMs. FISH testing increases this number to >90%. Cytogenetic abnormalities affect the prognosis of patients with MM.
Test Interpretation
Analytic Sensitivity/Specificity
>95%
Results
Result Reported | Genomic Abnormalities Detected | Interpretation and Clinical Implications |
---|---|---|
Normal FISH result | None | No evidence of any of the tested abnormalities Other abnormalities (for which this test does not include probes) are not excluded |
Abnormal FISH result (specific abnormalities will be reported) | One or more | Results suggest a clonal population of cells with clinical significance in MGUS, MM, and/or SMM Results should be correlated with clinical and other laboratory findings Use companion test 3002737 to monitor for positive results by FISH in future studies |
Limitations
- This test only detects genomic abnormalities specific to the probes used.
- When this test is ordered in conjunction with chromosome analysis (karyotype) and/or genomic microarray on low cellularity samples, this test will be prioritized due to the need for CD138+ cell enrichment prior to FISH.
- Microarray will be prioritized after FISH, followed by karyotype.
- This may impact the completion of lower priority tests.
- If enrichment fails yield to sufficient CD138+ cells, testing will be performed using unenriched cells if available.
References
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WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues, Rev 4th 2017
Swerdlow S, Campo E, Jaffe E, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. 4th ed. International Agency for Research on Cancer; 2017.
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NCCN - multiple myeloma v4.2024
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: multiple myeloma. Version 4.2024. Accessed May 2024.
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35637223
Hagen P, Zhang J, Barton K. High-risk disease in newly diagnosed multiple myeloma: beyond the R-ISS and IMWG definitions. Blood Cancer J. 2022;12(5):83.
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35560063
Rajkumar SV. Multiple myeloma: 2022 update on diagnosis, risk stratification, and management. Am J Hematol. 2022;97(8):1086-1107.
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26517360
Rajan AM, Rajkumar SV. Interpretation of cytogenetic results in multiple myeloma for clinical practice. Blood Cancer J. 2015;5(10):e365.
Aids in risk stratification of individuals with plasma cell neoplasms (monoclonal gammopathy of unknown significance [MGUS], smoldering multiple myeloma [SMM], multiple myeloma [MM]). Recommended at initial diagnosis and/or at disease progression. Refer to companion test for monitoring.