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Lab Manual for Moffitt-Long and Mount Zion

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Myeloma Prognostic Risk Score

Item Value
Approval req'd? Yes, if not ordered by Hematology-Oncology
Available Stat? No
Test code MYPRS
Performed by Signal Genetics
Sendout? yes
Method PCR and Microarray analysis
Collection Instructions DO NOT collect samples after 2:00 PM Thursday, Friday or on weekends.

Check the expiration date on the label of the EDTA lavendar tube provided from Signal Genetics. A non-heparinized syring must be used for the initial bone marrow collection. Remove needle from syringe and transfer the specimen to the sterile EDTA vacutainer tube provided. A clotted sample is not acceptable. Refrigerate EDTA tube immediately after collection. DO NOT FREEZE. Deliver kit/tube to laboratory asap.
Container type Special 6 mL lavender top tube provided by Signal Genetics available from hematology.
Amount to Collect 5 mL bone marrow aspirate
Sample type Bone marrow aspirate
Preferred volume 5 mL
Min. Volume 3 mL
Processing notes Deliver tube to Hematology lab for processing. Keep sample refrigerated. Fill out Signal Genetics MyPRS Test Request Form. Send samples with an ice pack in an addressed box provided by Signal Genetics.

Sample must be sent overnight Monday - Thursday. Saturday and Sunday delivery not available.
Normal range
Synonyms Molecular profiling; Multiple myeloma
Turn around times 7-10 days
Additional information Note re: Medicare
This test is used only after an initial diagnosis of multiple myeloma has been made and will be used in stratification of therapeutic interventions. Should these criteria not be met, denial will occur. The coverage is set to include only two clinical settings: 1.) once after initial diagnosis is made, and 2.) if relapse has occurred. Therefore ICD-9 codes 203.00 or 203.02 must be submitted for billing.Patient should sign an Advanced Beneficiary Notice before collecting sample if these neither of theses ICD-9 codes apply.

The myeloma prognostic risk score (MyPRSTM) test is a myeloma expression profiling analysis that allows risk stratification for plasma cell myeloma patients at initial diagnosis and relapse. Results are reported as high risk or low risk.

Information provided by Signal Genetics states:
"The MyPRSª test is based on assessing the expression (i.e., activity) levels of 70 specific genes in order to identify a high risk gene signature that is associated with poor clinical outcome and short survival. Plasma cells are retrieved by a bone marrow aspirate. A bone marrow aspirate is used in determining the diagnosis and establishing the prognosis of a number of conditions, including, multiple myeloma. Plasma cells from the bone marrow sample are enriched in order to provide the clearest assessment of these cells. Genetic material is then extracted from these plasma cells and analyzed. The results from this analysis are then compared to proprietary data bases that have been developed and validated over the course of 10 years of study involving thousands of plasma cell samples. This analysis results in a MyPRSª risk score that reflects the probability of early recurrence of the myeloma (high risk) or a maintenance of remission (low risk)."

"Several large clinical trials have shown that before any treatment, a high risk signature is present in approximately 15% of new cases of multiple myeloma, and a low risk signature is present in the remaining 85% of new cases [1]. A high risk signature at the time of diagnosis is associated with shorter durations of complete remission, event-free survival, and overall survival. When compared to other clinically used stratification systems, including the International Staging System (ISS) for multiple myeloma, the MyPRSª test remained a significant predictor of outcome. In addition to its ability to predict outcome of newly diagnosed multiple myeloma patients, a recent study also showed that the MyPRSª is also an independent and the most significant prognostic factor for survival in an analysis of relapsed multiple myeloma patients [2]."

REFERENCES:
[1] Shaughnessy JD, Jr., Zhan F, Burington BE, Huang Y, Colla S, Hanamura I, et al. A validated gene expression model of high-risk multiple myeloma is defined by deregulated expression of genes mapping to chromosome 1. Blood 2007;109:2276-84.
[2] Nair B, Shaughnessy JD, Jr., Zhou Y, Astrid-Cartron M, Qu P, van RF, et al. Gene expression profiling of plasma cells at myeloma relapse from tandem transplantation trial Total Therapy 2 predicts subsequent survival. Blood 2009;113:6572-5.
[3] Zhan F, Barlogie B, Mulligan G, Shaughnessy JD, Jr., Bryant B. High-risk myeloma: a gene expression based risk-stratification model for newly diagnosed multiple myeloma treated with high-dose therapy is predictive of outcome in relapsed disease treated with single-agent bortezomib or high-dose dexamethasone. Blood 2008;111:968-9.
[4] Mulligan G, Mitsiades C, Bryant B, Zhan F, Chng WJ, Roels S, et al. Gene expression profiling and correlation with outcome in clinical trials of the proteasome inhibitor bortezomib. Blood 2007;109:3177-88.
Last Updated 5/22/2013 1:17:08 PM
Entry Number 1382

If you have additional questions regarding this test, please call: 415-353-1667

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