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Specimen Collection Manual and Test Catalog

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FLT3 ITD MRD

Geisinger Epic Procedure Code:  LAB5260    Geisinger Epic ID:  209543
Test Restriction:  ORDER LIMITED TO HEM/ONC AND LABORATORY

SPECIMEN COLLECTION
Specimen type: 

EDTA whole blood, EDTA bone marrow, or DNA 


Preferred collection container: 
Specimen required: 

3 mL EDTA whole blood, minimum 1 mL; 1 mL EDTA bone marrow, minimum 0.25 mL; 1ug DNA 



SPECIMEN PROCESSING
Transport temperature: 

Refrigerated


Specimen stability: 

Room temperature: 3 days. Refrigerated: 7 days. Frozen: Unacceptable.



TEST DETAILS
Additional information: 

Indications for testing:

  • Stratifying risk for AML recurrence
  • Monitor internal tandem duplications (ITD) mutations in the FLT3 gene and evaluate for disease recurrence

CPT code(s):  0046U
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.
The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

Test includes: 

An interpretive report will be issued indicating whether FLT3 ITD MRD was detected. 


Methodology: 
Next Generation Sequencing
Synonyms: 

AML – FLT3 ITD MRD Assay


Clinical significance: 

Minimal residual disease (MRD) detection in patients with leukemia has proven to be useful in the clinical management of disease and can facilitate the development of new therapies.  Mutations in the fms-like tyrosine kinase 3 (FLT3) gene are the most prevalent mutations found in acute myeloid leukemia (AML) and are characterized by an aggressive phenotype with a high prevalence of relapse.  Internal tandem duplication (ITD) mutations within the juxtamembrane domain are the most common mutations of FLT3.  The development of a sensitive and specific assay for FLT3 ITD mutations represents a significant advancement in guiding treatment decisions.
LabPMM’s FLT3 ITD MRD test is an NGS-based, targeted, deep-sequencing assay that detects ITDs ranging from 3 bp to over 200 bp in size.  Once a specific ITD (length and sequence) has been identified in a primary sample, it can easily be tracked in subsequent samples at a sensitivity of 5 x 10-5, provided sufficient DNA quantity is tested.
The treatment of AML has become a paradigm for precision medicine.  This MRD assay is at least two orders of magnitude more sensitive than other commercially available FLT3 assays.  It detects the persistence of a driver mutation, FLT3 ITD, in patients with no overt evidence of disease, allowing clinicians to identify those patients that can benefit from continuation or modification of treatment.
MRD detection by Next-Generation Sequencing has demonstrated utility in predicting clinical outcomes and in generating clinically actionable results, allowing early intervention, confirmation of disease status prior to transplant, and increased confidence in remission status.


Doctoral Director(s): 
Randin Nelson MD
Review Date:  06/30/2026

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