ABL1 TKI Resistance Mutation Detection with Interpretation
| Label Mnemonic: | HEMEABL, HEMEABLBM |
| Epic code: |
LAB8915 for Blood LAB8919 for Bone Marrow |
| Order form: | Comprehensive Hematopathology Requisition |
| Supply order: | Supply Order Form |
| Billing: | Billing Policies |
| CPT code: | 81170 |
Specimen(s):
Blood or Bone Marrow Aspirate
Collection Medium:
|
| Pink top tube 6 mL (K2-EDTA) |
Minimum:
Whole blood (EDTA anti-coagulated; 6 mL pink top tube) or bone
marrow aspirate (EDTA anti-coagulated; pink or lavender top tube).
Rejection Criteria:
Serum or plasma. Specimens collected in anticoagulants other than
EDTA. Frozen Specimens.
Testing Schedule:
Weekly
Turn Around Time:
21 days
Reference Range:
No variants detected.
Comments:
Testing is for detection of ABL1 tyrosine kinase domain
mutations that confer resistance to TKI therapy in patients with
BCR-ABL1 positive chronic myelogenous leukemia (CML), acute
lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
This assay is not intended to be used for detection or quantification of BCR-ABL1 fusion transcripts.
Testing is recommended for patients who exhibit treatment failure as evidenced by rising BCR-ABL1 fusion transcript levels. A BCR-ABL1 fusion transcript level of 5%IS (percent International Standard) is necessary for testing.
The limit of detection for variants is 1.0% mutant allele fraction.
This assay is not intended to be used for detection or quantification of BCR-ABL1 fusion transcripts.
Testing is recommended for patients who exhibit treatment failure as evidenced by rising BCR-ABL1 fusion transcript levels. A BCR-ABL1 fusion transcript level of 5%IS (percent International Standard) is necessary for testing.
The limit of detection for variants is 1.0% mutant allele fraction.
Methodology:
RNA is isolated from whole blood. Reverse transcription and anchored
multiplex PCR are performed for targeted next-generation sequencing
(Illumina based sequencing) to detect variants in the ABL1 gene
spanning amino acids 85 – 559.
Instructions:
Testing requires dedicated collection tube.
Sample Processing:
Do Not Centrifuge.
Sample Storage:
Refrigerate.
Transport Instructions:
Place specimen into zip-lock type bag, seal bag.
Recommend early AM overnight shipping or equivalent if not on courier service.
Ship refrigerated.
Place requisition into outside pocket of bag.
Protect phlebotomy tube from excessive heat and ship in cooled container during summer months.
Recommend early AM overnight shipping or equivalent if not on courier service.
Ship refrigerated.
Place requisition into outside pocket of bag.
Protect phlebotomy tube from excessive heat and ship in cooled container during summer months.