ABL T315I Mutation in CML, Plasma-based, Leumeta (R) [19782X]

Test Code
19782

CPT Codes
81401

Preferred Specimen

6 mL whole blood collected in an EDTA (lavender-top) tube



Minimum Volume
4 mL

Instructions
Stability restrictions: Whole blood samples must be received in Chantilly Monday through Friday a.m. within 24 hours of collection.

Note:
Specimen is stabilized upon receipt at Nichols Institute, San Juan Capistrano.

Follow standard whole blood collection procedure. Collect 6 mL whole blood in an EDTA tube. Blood samples are shipped refrigerated. Do not freeze whole blood. After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. Ship sample immediately, due to short sample stability of 72 hours. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.

Transport Container
EDTA (lavender-top) tube

Transport Temperature
Refrigerated

Specimen Stability

Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable



Methodology
Polymerase Chain Reaction (PCR) • Fragment Analysis

This test was developed and its performance characteristics have been determined by Quest Diagnostics. Performance characteristics refer to the analytical performance of the test.

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 Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130



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.