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Multiple Myeloma-MGUS, MM-MGUS

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Updated Test Information:

Test Description
Multiple Myeloma-MGUS, MM-MGUS
Synonym(s)

Plasma Cell Myeloma, MM, MM-MGUS, Multiple Myeloma-Monoclonal Gammopathy of Undetermined Significance
General Information

Probes: TP53 (17p13.1)/CEP17 (17p11.2), D13S319 (13q14)/LAMP1 (13q34), CEP5 (5p12)/CEP9 (9p13.1p13.2)/CEP15 (15q11.2), CDKN2C (1p32.3)/CKS1B (1q21.3), CCND1 (11q13.3)/IGH (14q32.33), Reflex IGH Probe sets: MAF (16q23.2)/IGH (14q32.33), FGFR3 (4p16.3)/IGH (14q32.33) (probe sets may be ordered separately)


Disease(s): Plasma cell myeloma, Multiple Myeloma (MM)


Note: Plasma cell enrichment will be performed on bone marrow or peripheral blood samples unless our client specifies otherwise. (Peripheral blood is not recommended as a screening specimen unless increased plasma cells are seen on blood smear.) Specimens should be received as soon as possible and preferable no longer than 72 hours after collection. If enriched samples are insufficient to complete the whole panel, Incyte Diagnostics will prioritize probe based on pathologist or client preference.
Specimen Requirements

Bone Marrow
Peripheral Blood: Not recommended as a screening specimen unless increased plasma cells are seen on blood smear.
2-5 mL Sodium Heparin tube (preferred), EDTA tube (acceptable)
Specimens should be received in our laboratory within 72 hours of collection.
Additional Processing Details

Refrigerate specimen, Do Not Freeze. Use cold pack for transport, making sure cold pack is not in direct contact with specimen.
Required Information

Complete the Incyte Diagnostics hematology requisition with the patient's demographics and relevant clinical history. Label the specimen containers with patient's full name, second unique identifier, and specimen site/source. Please provide a copy of the patient's complete blood count (CBC) report.
Unacceptable Specimen Conditions

Specimen containers without two (2) patient identifiers, specimens submitted in inappropriate collection media, frozen specimens.
Department (code)

FISH
Methodology

Fluorescence in-Situ Hybridization (FISH)
Estimated TAT

3-5 working days from receipt. Add 1-3 days if reflexed
Testing Schedule

Monday-Friday
Retention

7 days after release of final report
CPT Code(s)

88377x5 manual without reflex; 88377x7 with reflex
Additional Information

Clinical Significance: The MM panel is used for the detection of FISH and chromosome aberrations useful in prognosis in plasma cell myeloma. As malignant plasma cells often have a low proliferation index, conventional cytogenetics frequently yields normal results. When this happens, interphase FISH studies can increase the abnormality detection rate.

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.

If Flow Cytometry studies are also being ordered, it is preferable to submit an EDTA (purple top) tube specifically for Flow Cytometry. if only one tube can be submitted, please submit one sodium heparin (green top) tube for both FISH and Flow Cytometry studies