BCR-ABL1 Mutation Analysis for Tyrosine Kinase Inhibitor Resistance by Next Generation Sequencing

2008420
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Example Reports
Detected
Not Amplified
Not Detected
COMPONENT DESCRIPTION TEST TYPE INFECTIOUS UNIT OF MEASURE NUMERIC MAP LOINC
2008421
BCR-ABL1 Mutation by NGS Source
Resultable
N
31208-2
2008422
BCR-ABL1 Mutation by NGS Result
Resultable
N
55135-8

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Additional Technical Information
Ordering Recommendation

Order only for patients with an established diagnosis of a BCR-ABL1 positive leukemia. This test is used to determine if a mutation is present that would interfere with response to TKI therapy in Philadelphia chromosome positive (Ph+) lymphoblastic leukemia or chronic myelogenous leukemia (CML). The test detects all common mutations, including T315I. For initial BCR-ABL1 testing, refer to BCR-ABL1, Qualitative with Reflex to BCR-ABL1 Quantitative (2005010).

Mnemonic
BCRABL NGS
Methodology

Massively Parallel Sequencing

Performed

Varies

Reported

10-12 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavendar (EDTA) or bone marrow (EDTA).

Specimen Preparation

Transport 5 mL whole blood or 3 mL bone marrow. (Min: 1 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Serum or plasma. Specimens collected in anticoagulants other than EDTA. Frozen Specimens. Clotted or serverely hemolyzed specimens.

Remarks
Stability

Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable

Reference Interval
Interpretive Data

Refer to report

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

For specimens having no t(9;22) fusion, this test will be canceled and the ABL1 Amplification Confirmation test will be ordered.

Hotline History
N/A
CPT Codes

81170

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Components
Component Test Code* Component Chart Name LOINC
2008421 BCR-ABL1 Mutation by NGS Source 31208-2
2008422 BCR-ABL1 Mutation by NGS Result 55135-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • ABL Mutation (BCR-ABL1 Kinase Domain Mutation Analysis)
  • ABL1 Mutation Analysis for Imatinib (BCR-ABL1 Kinase Domain Mutation Analysis)
  • BCR-ABL1 Domain Mutation Analysis
  • BCR-ABL1 Mutation (BCR-ABL1 Domain Mutation Analysis)
  • Gleevec Resistance Mutation Analysis (BCR-ABL1 Kinase Domain Mutation Analysis)
  • Imatinib Mesylate Resistance Analysis (BCR-ABL1 Kinase Domain Mutation)
  • Imatinib Resistance Analysis (BCR-ABL1 Kinase Domain Mutation Analysis)
  • TKI Therapy Resistance
BCR-ABL1 Mutation Analysis for Tyrosine Kinase Inhibitor Resistance by Next Generation Sequencing