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MYD88 L265P Mutation Analysis

Test ID: M MYD88 CPT Code: 81479

Expected Turnaround Time
7 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.

Clinical Information
Qualitative real-time PCR assay for the detection of MYD88 L265P mutation. This mutation is present in the majority of LPL cases including Waldenström’s macroglobulinemia. Detection of the MYD88 L265P mutation can aid in differentiation between LPL and other low-grade B-cell lymphoproliferative disorders which may appear similar to LPL. Detection of this mutation may be crucial for treatment decisions as LPL may be treated with chemotherapy or rituximab.

Requisition Forms

Specimen Requirements


Specimen Requirements
  • Whole Blood: 5mL (minimum, 3mL), EDTA preferred (NaHep accepted)
  • Bone Marrow Aspirate: 3mL (minimum 1mL), EDTA preferred (NaHep accepted)
  • Refrigerated Extracted DNA: 50 µl at 50 ng/µl
  • Frozen Extracted DNA: 50 µl at 50 ng/µl

Specimen Stability
  • Whole Blood: 30 days
  • Bone Marrow Aspirate: 30 days
  • Refrigerated Extracted DNA: 60 days
  • Frozen Extracted DNA: Long Term

Storage Requirements

 

  • Whole Blood: 2°C to 8°C
  • Bone Marrow Aspirate: 2°C to 8°C
  • Refrigerated Extracted DNA: 2°C to 8°C
  • Frozen Extracted DNA: ≤ -15°C

Shipping Recommendations
  • Whole Blood: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Bone Marrow Aspirate: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Refrigerated Extracted DNA: REFRIGERATED, Protect from extreme temperature with ice pack. Separate ice pack from specimen.
  • Frozen Extracted DNA: FROZEN, Ship samples on dry ice. Separate dry ice from specimens. 

Specimen Rejection Criteria

Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimens beyond stability; Insufficient DNA isolated


Test Details


Synonyms

MYD88 p.L265P


Keywords
Molecular Diagnostics, Chronic Lymphocytic Leukemia (CLL), Lymphoma, Mutation Analysis, DNA Sequencing, Genomics, Next Generation Sequencing

Test Method
Real-time polymerase chain reaction (RT-PCR)

Methodology Category
Molecular

Regulatory Status
RUO

Special Considerations
  • Frozen blood and bone marrow samples are NOT accepted.
  • Extracted DNA: Isolation of nucleic acids for clinical testing must occur in a CLIA-certified laboratory or a laboratory meeting equivalent requirements. Concentration and volume must be provided for all samples.

Associations

Lymphoplasmacytic lymphoma (LPL); Waldenström’s macroglobulinemia, chronic lymphocytic leukemia (CLL); diffuse large B-cell lymphoma (DLBCL)