ABL Kinase Domain Mutation in CML, Cell-based : 1004211

Test Code
BCRNGS or 1004211

CPT Codes
81170

Instructions
Lavender (EDTA), Sodium heparin (green-top), or ACD solution B (yellow-top) tube whole blood or bone marrow.

Transport Container
Transport 6 mL whole blood  (Min: 4 mL) OR Transport 2.1 mL bone marrow. (Min: 1 mL).

Transport Temperature
Refrigerated.

Specimen Stability
Room temperature: 72 hours; Refrigerated: 72 hours; Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis, Lipemia, Frozen samples, Clotted whole blood samples, Clotted bone marrow samples.

Methodology
Nested Polymerase Chain Reaction, Real-Time Polymerase Chain Reaction (RT-PCR), Sequencing

Setup Schedule
Sunday & Wednesday

Report Available
3-7 days (From receipt at performing laboratory)

Limitations
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.

Reference Range
See laboratory report.

Clinical Significance
Imatinib mesylate (ST1571;Gleevec) is a selective BCR-ABL kinase inhibitor, effective in the treatment of chronic myelogenous leukemia (CML). Most patients in chronic phase maintain durable responses; however, many in blast crisis fail to respond, or relapse quickly. ABL kinase domain mutations are the most commonly identified mechanism associated with relapse. The molecular monitoring in the first few months of therapy may play a crucial role in detecting patients at high risk of Imatinib resistance. This ABL kinase mutation assay may detect drug-resistant mutations before clinical relapse and identify candidate suitable for alternative therapy.

Performing Laboratory
Quest Diagnostics



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.