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ABL Kinase Domain Mutation
Test Code16029
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
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
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.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
Refrigerated: 72 hours
Frozen: Unacceptable
Methodology
Real-Time Polymerase Chain Reaction • Nested 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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 3-5 days
Clinical Significance
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.
