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Test Directory » ABL Kinase Domain Mutation in CML, Cell-based

Test Directory ABL Kinase Domain Mutation in CML, Cell-based

ABL Kinase Domain Mutation in CML, Cell-based

Order Code: ABLKIN

Test Summary

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.

Aliases

Specimen Collection

Special Instructions

N/A

Preferred Specimen

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

Minimum Volume

3 mL whole blood • 1 mL bone marrow aspirate

Instructions

Do not reject specimens, send to laboratory for screening

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.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

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

Limitations

N/A

Other Acceptable Specimens

Whole blood collected in: sodium heparin (green-top), ACD solution B (yellow-top) tube • 3 mL bone marrow aspirate collected in: sodium heparin (green-top) tube

Unacceptable Specimens

Grossly hemolysis • Lipemia • Frozen samples • Clotted whole blood samples • Clotted bone marrow samples

Order Code

ABLKIN

EPIC (Premier) Code

LAB5781

Includes

N/A

CPT Code

81170

Billing Code

670510

CPT Statement

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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly VA, 20153

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 3 - 5 days