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MYD88, Mutation Analysis
Test Code91771
CPT Codes
81305
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube
Minimum Volume
2 mL whole blood • 0.5 mL bone marrow • 6 slides
Other Acceptable Specimens
Whole blood collected in: Sodium heparin (green-top) or ACD-B (yellow-top) tube • 2 mL bone marrow aspirate collected in an EDTA (lavender-top) tube • Formalin-fixed, paraffin-embedded tissue block • 10 slides tissue submitted in a slide holder • Extracted DNA from CLIA-certified laboratory
Transport Temperature
Room temperature
Specimen Stability
Whole blood and bone marrow
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
FFPE/Slides
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Extracted DNA
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 1 year
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
FFPE/Slides
Room temperature: Indefinitely
Refrigerated: Indefinitely
Frozen: Unacceptable
Extracted DNA
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 1 year
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Frozen specimens
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Monday-Sunday Morning
Report available: 7 Days
Report available: 7 Days
Reference Range
Not detected
Clinical Significance
L265P mutation in the MYD88 gene is found in approximately 90% of WaldenstrÖm macroglobulinemia and IgM-expressing lymphoplasmacytic lymphoma (LPL). There is a low incidence of L265P MYD88 mutation in other systemic CD5-negative B-cell lymphoproliferative disorders including atypical chronic lymphocytic leukemia, nodal marginal zone lymphoma (MZL), splenic MZL and mucosa-associated lymphoid tissue (MALT)-type MZL.
This PCR-based DNA pyrosequencing assay sensitively detects the L265P MYD88 mutation and can be used to help diagnose WaldenstrÖm macroglobulinemia or IgM-expressing lymphoplasmacytic lymphoma and to help in stratifying or subclassifying patients with IgM monoclonal gammopathy.
This PCR-based DNA pyrosequencing assay sensitively detects the L265P MYD88 mutation and can be used to help diagnose WaldenstrÖm macroglobulinemia or IgM-expressing lymphoplasmacytic lymphoma and to help in stratifying or subclassifying patients with IgM monoclonal gammopathy.
