ABL Kinase Domain Mutation in CML, Cell-based
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
- N/A
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.
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
- 700000
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
14225 Newbrook Drive
Chantilly VA, 20153
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 3 - 5 days
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.
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
Result Information
Methodology
Nested Polymerase Chain Reaction • Real-Time Polymerase Chain Reaction • Sequencing
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 3 - 5 days