BCR/ABL1 Mutation Analysis for Tyrosine Kinase Inhibitor Resistance by NGS




Test Mnemonic

KINASE

CPT Codes

  • 81170 - QTY (1)

Performing Laboratory

ARUP

FDA Category

Laboratory Developed Test


Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
5 mLWhole bloodEDTA (Lavender) RefrigeratedCritical refrigerated. Specimen must be delivered to Cleveland Clinic Laboratories by 3 p.m. DO NOT collect the day before or the day of a major holiday. Separate specimens must be submitted when multiple tests are ordered.

Alternate Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
3 mLBone marrowEDTA (Lavender) RefrigeratedCritical refrigerated. Specimen must be delivered to Cleveland Clinic Laboratories by 3 p.m. DO NOT collect the day before or the day of a major holiday. Separate specimens must be submitted when multiple tests are ordered.

Minimum Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
1 mL     

Stability

Environmental Condition Description
Refrigerated48 hours
Ambient1 hour
FrozenUnacceptable

Days Performed

Varies

Turnaround Time

11 - 13 days

Methodology

Name Description
Massive Parallel Sequencing 

Reference Range

Special Info

Serum, plasma, and specimens collected in anticoagulants other than EDTA are unacceptable. Frozen, clotted or severely hemolyzed specimens will be rejected. For specimens having no t(9;22) fusion, this test will be canceled, and an ABL1 amplification confirmation test will be ordered. This test is New York DOH approved.

Clinical Info

Order only for patients with an established diagnosis of a BCR-ABL1 positive leukemia. 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). This test detects all common mutations, including T315I.