ABL Kinase Domain Mutation in CML,Plasma-based, Leumeta® [16031X]

Test Code
16031

CPT Codes
81170

Preferred Specimen
6 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume
4 mL

Instructions
Stability restrictions: Samples must arrive in Chantilly Monday through Friday a.m. within 24 hours of collection.
Note:
Information regarding draw time and date is required to ensure stability of the sample is maintained.
To avoid contamination, the laboratory at SJC will separate the plasma upon arrival. Follow standard whole blood collection procedure. Collect whole blood samples in an EDTA tube. Blood samples are shipped refrigerated. Do not freeze whole blood. After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. Ship sample immediately due to short sample stability of 72 hours. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.

Transport Temperature
Refrigerated (cold packs)


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

Methodology
Nested Polymerase Chain Reaction • Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) • Sequencing

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
The plasma based molecular assay is based on the new concept that in hematological diseases, tumor cell pour into their circulation their DNA and RNA, these components can be detected in plasma. 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 Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130



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.