ABL Kinase Domain Mutation : 16029

Message
Ship specimen immediately due to short specimen stability of 72 hours.


Test Code
BCRNGS or 16029


CPT Codes
81170

Instructions
Whole blood or bone marrow in lavender (EDTA) or green (no gel) (sodium heparin) tube.  Also yellow (ACD Solution B) tube for whole blood.


Transport Container
Transport 5 mL whole blood  (Min: 3 mL) OR Transport 3 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
Not Detected


Clinical Significance
ABL Kinase Domain Mutation in CML – Kinase inhibitors such as IMATINIB mesylate (ST1571;GLEEVEC) are effective in the treatment of chronic Myelogenous Leukemia (CML) by selectively inhibiting BCR-ABL fusion protein. 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 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 resistance to therapy. The ABL kinase mutation assay sequences exons 4-9 of ABL1 kinase and will detect all drug-resistance mutations as recommended by guidelines including G250E, Y253H, E255K/V, V299L, F311L/V/I, T315I/A, F317L/V/I/C, A337T, F359V/I/C and P465S, which will aid in the selection of the appropriate kinase inhibitor therapies.


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.