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FLT3 Mutation Analysis

Test ID: M FLT3 CPT Code: 81245, 81246
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
The FLT3 Mutation Analysis assay qualitative detects FLT3 ITD and TKD mutations and is intended primarily for use with patients newly diagnosed with AML to assist with therapeutic, diagnostic, and prognostic treatment decisions.
Requisition Forms
Oncology Pathology Requisition

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

FLT3 gene, ITD mutation

Keywords
Leukemia, Molecular Diagnostics, Oncology, Acute Myeloid Leukemia (AML), Mutation Analysis
Test Method
Polymerase chain reaction (PCR) and capillary gel electrophoresis.
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

Acute myelogenous leukemia (AML)