ABL Kinase Domain Mutation

Test code

16029

CPT code(s)*

81170

**CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.

Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide Service Area Information to find available tests you can order.

In-home collection may be available in your area for purchase through Quest Mobile.

Clinical significance

ABL Kinase Domain Mutation - 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…

Test resources

Details

Test details

Methodology

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

Assay category

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.

Alternative name(s)

ABL Mutation

Specimen requirements
Patient preparation	None Specified
Preferred specimen(s)	5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube
Alternative specimen(s)	Whole blood collected in: Sodium heparin (green-top) tube or ACD solution B (yellow-top) tube • Bone marrow aspirate collected in: Sodium heparin (green-top) tube
Minimum volume	3 mL whole blood • 1 mL bone marrow
Collection 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 stability 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

Reference range(s)

Not Detected

LOINC® codes

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Service Area Information

Performing lab & setup schedule

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Service Area Information

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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