When this test is ordered, pre-analysis cell sorting will be performed at an additional charge.
For diagnostic samples, all probes in the initial panel will be evaluated if sufficient plasma cells are identified. The initial panel includes testing for the following abnormalities using the probes listed:
1q gain, TP73/1q22
14q32 rearrangement, IGH
Based on the results from the initial panel, reflex testing may be performed to identify the following abnormalities using the probes listed:
For follow-up samples, only TP73/1q22, TP53/D17Z1 and MYC probes will be tested. If a diagnostic sample was uninformative for a probe set due to an insufficient number of plasma cells, attempts may be made to achieve results for the missing probe on a subsequent sample (if sufficient plasma cells are identified).
Initial screening will be performed to determine if sufficient plasma cells are present within the provided specimen.
If the specimen is received greater than 96 hours from collection, or arrives clotted or hemolyzed, this test will be canceled and MFCF / Myeloma, FISH, Fixed Cells will be added as the more appropriate test.
EDTA Lavender top tube (LTT)
Heparin Green top tube (GTT)
Advisory Information:This assay detects high risk abnormalities plus CCND1/IGH fusion observed in the bone marrow of patients with a plasma cell disorder.
-For a more complete genetic evaluation, order MPCDS / mSMART, Plasma Cell Proliferative Disorder, FISH, Bone Marrow.
-For paraffin-embedded tissue specimens, order PLASF / Plasma Cell Proliferative Disorder, FISH, Tissue.
-For fixed cell pellet specimens, order MFCF / Myeloma, FISH, Fixed Cells.
-Testing will be changed to the appropriate test if this test is ordered on either of the previous specimens or if bone marrow specimens are received more than 96 hours from collection.
This test is not approved by the FDA and is best used as an adjunct to existing clinical and pathologic information.
Multiple myeloma is a hematologic neoplasm that generally originates in the bone marrow and develops from malignant plasma cells. There are four main categories of plasma cell proliferative disorders (PCPD): monoclonal gammopathy of undetermined significance (MGUS), monoclonal immunoglobulin deposition diseases (amyloidosis), plasmacytoma, and multiple myeloma. MGUS, which occurs in 3% to 4% of individuals over age 50 years, represents the identification of an asymptomatic monoclonal protein, yet approximately 1% per year will progress to multiple myeloma. Amyloidosis represents a rare group of deposition disorders including primary amyloidosis vs. light chain and heavy chain disease. Plasmacytomas represent isolated collections of bone or extramedullary plasma cells with a risk for development of multiple myeloma. Generalized bone pain, anemia, limb numbness or weakness, symptoms of hypercalcemia, and recurrent infections are all symptoms that may indicate multiple myeloma.
As myeloma progresses, the malignant plasma cells interfere with normal blood product formation in the bone marrow resulting in anemia and leukopenia. Myeloma also causes an overstimulation of osteoclasts, causing excessive breakdown of bone tissue without the normal corresponding bone formation. These bone lesions are seen in approximately 66% of myeloma patients. In advanced disease, bone loss may reach a degree where the patient suffers fractures easily.
Multiple myeloma is increasingly recognized as a disease characterized by marked cytogenetic, molecular, and proliferative heterogeneity. This heterogeneity is manifested clinically by varying degrees of disease aggressiveness. Multiple myeloma patients with more aggressive disease experience suboptimal responses to some therapeutic approaches; therefore, identifying these patients is critically important for selecting appropriate treatment options.