ABL Kinase Domain Mutation in CML, Cell-based

Test Code

16029

CPT Codes
81170

Preferred Specimen

5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube

Minimum Volume

1 mL bone marrow • 3 mL whole blood

Other Acceptable Specimens

Whole blood collected in: Sodium heparin (green-top) tube, ACD solution B (yellow-top) tube • Bone marrow aspirate collected in: Sodium heparin (green-top) tube

Instructions

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 stabililty of the sample cannot be determined, delay in result or cancellation of test may occur. Do not reject specimens, send to laboratory for screening.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

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

Methodology
Nested Polymerase Chain Reaction • Real-Time Polymerase Chain Reaction • Sequencing

FDA Status
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.

Setup Schedule

Daily

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 Nichols Institute-Chantilly VA

14225 Newbrook Drive

Chantilly, VA 20151-2228

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.