Ordering Recommendation

Use to assess for single gene mutations, including substitutions and smaller insertions and deletions, that may have prognostic and/or therapeutic significance in acute myeloid leukemia (AML).

New York DOH Approval Status

Testing is not New York state approved. Specimens from New York clients will be sent out to a New York state-approved laboratory.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), Green (sodium heparin) Bone Marrow (EDTA) or Bone Marrow (sodium heparin), Fresh-frozen tissue.
New York State Clients: Lavender (EDTA)

Specimen Preparation

Whole Blood and Bone Marrow: Transport 3 mL. (Min: 1.5 mL)
Fresh-Frozen Tissue: Transport 5 mg fresh-frozen tissue.
Separate specimens must be submitted when multiple tests are ordered.
New York State Clients: 5 mL whole blood or bone marrow (Min: 2 mL)

Storage/Transport Temperature

Whole Blood or Bone Marrow: Refrigerated.
Fresh-Frozen Tissue: Frozen.
New York State Clients: Ambient

Unacceptable Conditions

Serum, plasma, grossly hemolyzed specimens, buccal brush or swab, FFPE tissue

Remarks

Specimen source is required

Stability

Whole Blood or Bone Marrow: Ambient: 72 hours; Refrigerated: 1 week; Frozen: Unacceptable
Fresh-Frozen Tissue: Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 1 month

Methodology

Massively Parallel Sequencing

Performed

Varies

Reported

12-14 days

Reference Interval

By report

Interpretive Data

Refer to report.

Compliance Category

Laboratory Developed Test (LDT)

Note

Genes tested: ANKRD26, ASXL1, CEBPA, DDX41, DNMT3A, ETV6, FLT3, GATA2, IDH1, IDH2, KIT, KRAS, NPM1*, NRAS, RUNX1, TP53, WT1
*One or more exons are not covered by sequencing for the indicated gene; see Additional Technical Information.

Hotline History

N/A

CPT Codes

81450

Components

Component Test Code* Component Chart Name LOINC
3002715 Acute Myeloid Leukemia Specimen
3002716 Acute Myeloid Leukemia Interp
3002718 EER, AML Panel by NGS 11502-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

Acute Myeloid Leukemia Mutation Panel by Next Generation Sequencing