Acute Myeloid Leukemia Prognostic Panel (Normal Karyotype)

Test Code

CPT Codes
81218, 81245, 81246, 81310

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

Preferred Specimen
6 mL whole blood collected in an EDTA (lavender-top) tube, and 2 mL whole blood collected in an EDTA (lavender-top) tube, or sodium heparin (green-top) tube

Minimum Volume
1st whole blood: 3 mL • 2nd whole blood: 1 mL • 1 mL bone marrow

Other Acceptable Specimens
3 mL bone marrow collected in an EDTA (lavender-top) tube and sodium heparin, or

Cell pellet and whole blood or bone marrow collected in a sodium heparin (green-top) tube

This assay is also designed for the remnant cell pellet from Cytogenetics. The cell pellet usually fixed should be transported at room temperature or refrigerated to the laboratory as soon as possible. Please provide a copy of the Cytogenetics report. Whole blood or bone marrow in green-top sodium heparin or EDTA (lavender-top) is required and the only acceptable specimen for the LabPMM portion of the testing.

Component- FLT3 ITD and TKD Mutation: Cell pellet specimens will be charged for testing, if repeat testing is needed.

Transport Temperature
Room temperature

Specimen Stability
Whole blood and bone marrow
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Cell pellet (acceptable)
Room temperature: See instructions

See individual tests

FDA Status
**This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

*The Laboratory for Personalized Molecular Medicine™ is CLIA certified and CAP accredited to perform high complexity testing. This test was developed and its performance characteristics determined by Invivoscribe, Inc. It has been approved by the U.S. Food and Drug Administration for use in the aid of prescribing midostaurin or gilteritinib (PMA# P160040). The Laboratory for Personalized Molecular Medicine performs the assay in accordance with the instructions for use provided by Invivoscribe, Inc.

Setup Schedule
Set up and Report available: See individual tests

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 Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92675

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.