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Acute Myeloid Leukemia Prognostic Panel (Normal Karyotype)

Test Summary

This testing, consisting of FLT3, NPM-1, and CEBPA, is recommended in the NCCN guidelines for determination of AML risk status in patients with cytogenetically normal AML. The presence of CEBPA gene mutations is associated with increased disease-free survival and overall survival. Mutations in NPM1 gene is a predictor of favorable prognosis and good response to induction chemotherapy. The presence of (FLT3) internal tandem duplication is associated with short disease-free survival.

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL whole blood

Instructions

Do Not Reject.
Send to lab for evaluation. Submission of whole blood (preferred): Follow standard whole blood collection procedure. Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4 degrees C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.

Cell Pellet Instructions: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Whole blood, bone marrow, tissue: Room temperature
Cell pellet: Refrigerated (cold packs)

Specimen Stability

  • Whole Blood / Bone Marrow
  • Room Temperature = 7 days
  • Refrigerated = 7 days
  • Frozen = Unacceptable
  • Cell Pellet
  • Room Temperature = Unacceptable
  • Refrigerated = 30 days
  • Frozen = 30 days
  • Tissue
  • Room Temperature = Preferred
  • Refrigerated = Acceptable
  • Frozen = Unacceptable

Limitations

N/A

Other Acceptable Specimens

3 mL (1 mL minimum) bone marrow collected in an EDTA (lavender-top) tube

Cell pellet collected in a sterile transport tube

5x5 mm (2x3 mm minimum)t issue collected in a paraffin block

Unacceptable Specimens

Do not reject

Order Code

AMLPP

EPIC (Premier) Code

LAB5251

Includes

CEBPA Mutation Analysis
NPM (Exon 12) Mutation Analysis, Cell-based
FLT3 Mutation Assay

CPT Code

  • 81218
  • 81310
  • 81245
  • 81246

Billing Code

  • 670845
  • 670846
  • 670847
  • 670848

CPT Statement

Methodology

See individual tests

FDA Status

CEBPA Mutation Analysis and NPM (Exon 12) Mutation Analysis, Cell-based: 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.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

See individual assays

Specimen Collection

Special Instructions

N/A

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL whole blood

Instructions

Do Not Reject.
Send to lab for evaluation. Submission of whole blood (preferred): Follow standard whole blood collection procedure. Collect 3-5 mL whole blood samples in EDTA tube. Blood samples are shipped at room temperature or 4 degrees C. Do not freeze whole blood. Record the draw time and date on the tube. Ship immediately to maintain sample stability.

Cell Pellet Instructions: This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Whole blood, bone marrow, tissue: Room temperature
Cell pellet: Refrigerated (cold packs)

Specimen Stability

  • Whole Blood / Bone Marrow
  • Room Temperature = 7 days
  • Refrigerated = 7 days
  • Frozen = Unacceptable
  • Cell Pellet
  • Room Temperature = Unacceptable
  • Refrigerated = 30 days
  • Frozen = 30 days
  • Tissue
  • Room Temperature = Preferred
  • Refrigerated = Acceptable
  • Frozen = Unacceptable

Limitations

N/A

Other Acceptable Specimens

3 mL (1 mL minimum) bone marrow collected in an EDTA (lavender-top) tube

Cell pellet collected in a sterile transport tube

5x5 mm (2x3 mm minimum)t issue collected in a paraffin block

Unacceptable Specimens

Do not reject

Billing

CPT Code

  • 81218
  • 81310
  • 81245
  • 81246

Billing Code

  • 670845
  • 670846
  • 670847
  • 670848

CPT Statement

Result Information

Methodology

See individual tests

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

See individual assays