FLT3 ITD MRD

Test Code

12542

CPT Codes
81245<br>This test is not available for New York patient testing<br>Restricted Client Code

Preferred Specimen

3 mL peripheral blood collected in an EDTA (lavender-top) tube

Minimum Volume

1 mL whole blood • 0.25 mL bone marrow

Other Acceptable Specimens

1 mL bone marrow collected in an EDTA (lavender-top) tube • 1 ug of previously isolated DNA submitted in a sterile transport tube

Instructions

Prefer to receive blood or bone marrow refrigerated. Room temperature specimens will need to be shipped next day. Only send DNA under unusual circumstances.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Whole blood and bone marrow
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable

Isolated DNA
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 14 days

Methodology
Polymerase Chain Reaction

FDA Status
This test was developed and its performance characteristics determined by the Laboratory for Personalized Molecular Medicine™. It has not been cleared or approved by the U.S. Food and Drug Administration. However, such approval is not required for clinical implementation, and test results have been shown to be clinically useful.

Setup Schedule

Set up Varies; Report available: 7-10 days

Reference Range

Not detected

Clinical Significance

To track and identify previously detected FLT3 ITD mutations in post-treatment follow-up samples, a multiplex master mix targeting the juxtamembrane domain of the FLT3 gene is used to amplify DNA extracted from a patient sample.

Next-generation sequencing of the PCR products is used to identify DNA sequences specific to previously identified mutations detected at diagnosis. Bioinformatics tools facilitate the detection of these specific sequences present at an allelic sensitivity level of 5 x 10-5.
• Stratifying risk for AML recurrence
• Monitor internal tandem duplications (ITD) mutations in the FLT3 gene and evaluate for disease recurrence

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.