BCR-ABL1 Gene Quant, PCR 91065

Test Code
BCRABLPCR

Alias/See Also
BCRABLPCR

CPT Codes
VARIES

Includes
If P190 transcript expression was previously documented, only P190 BCR-ABL1 will be performed at an additional charge (CPT code: 81207).
If P210 transcript expression was previously documented, only P210 BCR-ABL1 will be performed at an additional charge (CPT code: 81206).
If no prior positive is documented P190 BCR-ABL1 and P210 BCR-ABL1 will be performed at an additional charge (CPT code(s): 81206, 81207).

Preferred Specimen
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube

Minimum Volume
1

Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in: sodium heparin (green-top) tube

Instructions
Draw one lavender tube. Order needs go into 360 due to reflexing

Transport Container
LAV

Transport Temperature
T

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

Methodology

Quantitative Real-Time Polymerase Chain Reaction (PCR)

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

Setup Schedule
Set up: Daily; Report available: 4 days

Reference Range

BCR-ABL1/ABL1 %	0.000
BCR-ABL1/ABL1 % (IS)	0.000
Interpretation	See Laboratory Report

Clinical Significance
The Philadelphia Chromosome (Ph) is a translocation between chromosome 9 and 22 t(9; 22) (q34; Q11) that is found in more than 90-95% of chronic myeloid leukemia (CML), and in 20-25% of adult and 2-10% of childhood acute lymphoblastic leukemia (ALL). In CML, most translocations fall in the major breakpoint cluster region of the BCR gene, and result in either of two BCR-ABL1 mRNA molecules having an e13a2 junction (fusion of BCR exon 13 with ABL1 exon 2) or an e14a2 junction (fusion of BCR exon 14 with ABL1 exon 2) that encodes the p210 BCR-ABL1 fusion protein. In all, about two thirds of the BCR breakpoints fall in the minor breakpoint cluster region of the BCR gene, and the hybrid BCR-ABL1 transcript contains an e1a2 junction (fusion of BCR exon1 with AB11 exon2) which is translated as a p190 BCR-ABL1 fusion protein. Quantitative measurement of the changes of BCR-AB1 expression levels over time is important to monitor disease progression and response to targeted therapies. This test is a reverse-transcription pcr-based quantitative assay which detects these two major BCR-AB11 mRNA transcripts produced by the t(9; 22) chromosomal translocation (p210 and p190). BCR-ABL1 transcript levels are expressed as a percent ratio of BCR-ABL1 to the normalizing ABL1 transcript levels. For the p210 transcript associated with CML, quantitation is further adjusted to the international scale (IS) to allow comparison with other IS-compliant BCR-ABL1 assays. Optimal therapy in CML is associated with transcript levels below the major molecular response (MMR) milestone indicated by a BCR-ABL1/ABL1% (is) below 0.1.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153

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.