Acute Myeloid Leukemia Prognostic Panel (Normal Karyotype)

For Specimen Integrity during Extreme Weather see the “Lockbox Usage in Extreme Weather” document at the top of this page.

Test Code

CPT Codes
81218, 81310, 81245, 81246

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

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

Minimum Volume
3 mL whole blood

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

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.

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
     Room Temperature = Preferred
     Refrigerated = Acceptable
     Frozen = Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Do not reject

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.

Setup Schedule
Set up and Report available: See individual assays

Reference Range
See Laboratory Report

Clinical Significance
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.

Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042

Last Updated: November 24, 2021

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.