ABL T315I Mutation in CML, Cell-based : 1015285

Test Code
AT315Q or 1015285

CPT Codes
81401

Instructions
Whole blood or bone marrow in lavender (EDTA) tube.

Transport Container
Transport 6 mL (Min: 4 mL) whole blood or 3 mL (Min: 1 mL) bone marrow. Do not freeze whole blood or bone marrow. Ship sample immediately due to short stability of 72 hours.

Transport Temperature
Refrigerated.

Specimen Stability
Ambient: 72 hours; Refrigerated: 72 hours; Frozen: Unacceptable

Methodology
Fragment Analysis, Polymerase Chain Reaction (PCR)

Setup Schedule
Tuesday & Saturday

Report Available
3-6 days (From receipt at performing laboratory)

Limitations
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range
Negative

Clinical Significance
Mutations in the kinase domain of Bcr-abl are the leading cause of acquired imatinib resistance. Although mutations have been identified in more than 30 different amino acids, the highest degree of resistance was associated with single-point mutation T315I of the abl gene in the Bcr-abl fusion transcript. Early detection of T315I mutation of CML patient in therapy or pre-therapy could allow alternative treatment before resistance is detected cytogenetically or before disease progression become evident.

Performing Laboratory
Quest Diagnostics



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.