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BCR ABL1 Gene Rearrangement Test

BCR ABL1 Qualitative Test, BCR-ABL Gene Rearrangement Test, BCR ABL Gene Rearrangement Test, CML, t(9;22), chronic myelogenous leukemia, ALL, acute lymphoblastic leukemia, major, minor, breakpoint

Test Codes

EPIC: LAB6378, Beaker: GBCRG

Department

Molecular Pathology

Instructions

Samples should be drawn as early in the day as possible so they can be delivered to the Laboratory the same day.

Specimen Collection Criteria

Collect: Blood OR Bone Marrow

• Blood: 10.0 mL whole blood in Lavender-top EDTA tubes. (Minimum: 5.0 mL)
• Bone Marrow: 1.0 mL bone marrow aspirate in a Lavender-top EDTA tube. (Minimum: 0.5 mL)
• Other specimen types require the approval of the Medical or Technical Director.

Physician Office/Draw Specimen Preparation

Do not freeze specimens. Maintain specimens at room temperature (20-26°C or 68-78.8°F) or refrigerate (preferred) (2-8°C or 36-46°F) if the specimen will not be received in the laboratory within 6 hours of collection.

Preparation for Courier Transport

Transport: Whole blood or bone marrow aspirate refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Frozen specimens. 
• Centrifuged specimens.
• Mislabeled or unlabeled tubes. 
• Specimens collected in heparin tubes (Green-top), clot tubes (Red-top) ACD anti-coagulant tubes, or SST tubes.
• Specimens not collected and processed as indicated.

Client will be notified of any cancellation of testing.

In-Lab Processing

Do not freeze specimens. Maintain specimen refrigerated (2-8°C or 36-46°F) prior to testing. 

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 6 hours
Refrigerated (2-8°C or 36-46°F): 48 hours
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

N/A - entire specimen extracted for RNA upon arrival in the Molecular Laboratory.

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

Once per week.
Results available in 7–10 days.

Reference Range

Negative (no gene rearrangement).

Test Methodology

RNA extraction and analysis for BCR-ABL fusion transcript from whole blood or bone marrow using the reverse transcriptase and the polymerase chain reaction (RT-PCR) followed by fragment analysis.

Interpretation

The test is diagnostic for chronic myeloid leukemia (CML) and is a prognostic indicator in acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). It is also predictive of responsiveness to targeted tyrosine kinase inhibitor therapy in these conditions.

Clinical Utility

• This test is used for the detection of BCR-ABL gene rearrangement for the diagnosis and monitoring of CML, ALL, and AML patients.
• The test is required for the diagnosis of CML, also to rule out CML in all other myeloproliferative neoplasms; for ALL patients, both pediatric and adults, the test is recommended for risk stratification.
• Breakpoints Identified: Minor (p190) - e1a2, e1a3 | Major (p210) - e14a2 (b3a2), e14a3 (b3a3), e13a2 (b2a2), e13a3 (b2a3).

CPT Codes

81206, 81207.

Contacts

Last Updated

10/30/2023