MYD88, Mutation Analysis
Order Code:
MYDMUT
Test Summary
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.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
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
Instructions
N/A
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Whole blood and Bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- Tissue block and slides
- Room temperature: Indefinitely
- Refrigerated: Indefinitely
Limitations
N/A
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
Unacceptable Specimens
Frozen specimens
Order Code
MYDMUT
EPIC (Premier) Code
LAB6370
Includes
N/A
CPT Code
- 81305
Billing Code
- 670865
CPT Statement
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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153
14225 Newbrook Drive
Chantilly VA, 20153
Department
Reference Testing
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday - Sunday morning; Report available: 7 days
Specimen Collection
Special Instructions
N/A
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
Instructions
N/A
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Room temperature
Specimen Stability
- Whole blood and Bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- Tissue block and slides
- Room temperature: Indefinitely
- Refrigerated: Indefinitely
Limitations
N/A
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
Unacceptable Specimens
Frozen specimens
Result Information
Methodology
Next Generation Sequencing
Testing Laboratory
N/A
Reference Range
Not detected
Setup Schedule / Expected Turnaround Time
Monday - Sunday morning; Report available: 7 days