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

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Time Sensitive

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Additional Technical Information

Ordering Recommendation

Order only for patients with an established diagnosis of a BCR-ABL1-positive leukemia. Use to determine if a variant is present that would interfere with response to TKI therapy in Philadelphia chromosome positive (Ph+) lymphoblastic leukemia or chronic myelogenous leukemia (CML). Detects all common mutations, including T315I. For initial BCR-ABL1 testing, refer to Diagnostic Qualitative BCR-ABL1 Assay with Reflex to p190 or p210 Quantitative Assays (3005839).

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

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

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