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MYD88, Mutation Analysis

Test Code
MYD88


Alias/See Also
91771


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 collected in: EDTA (lavender-top) tube or sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue block • 10 slides tissue submitted in a slide holder • Extracted DNA from CLIA-certified laboratory or cell pellet


Transport Temperature
Room temperature


Specimen Stability
Whole blood and bone marrow
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Paraffin block and 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 after receipt at the performing laboratory. Add two (2) days for transport.


Reference Range
Not detected


Clinical Significance
Oncogenic mutations in MYD88, in particular the L265P mutation, have been identified as driver mutations in various B-cell lymphomas. The L265P mutation is found in approximately 90% of Waldenstom 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 next-generation sequencing (NGS) based assay detects clinically significant MYD88 mutations, including the L265P mutation and can be used to help diagnose Waldenstrom macroglobulinemia or IgM-expressing lymphoplasmacytic lymphoma and to help in stratifying or subclassifying patients with IgM monoclonal gammopathy.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153


Last Updated: May 4, 2023


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.