t(14;18) IGH/BCL2 Fusion Detection, Quantitative PCR

Indication

For diagnosis and post-treatment residual disease monitoring of patients with t(14;18) carrying lymphomas.

Methodology

Quantitative analysis of mbr fusion sites by real-time PCR, with co-amplification of an internal standard, cyclophilin, as a normalizer. Size of the fusion product is determined by capillary electrophoresis to allow accurate sequential monitoring of the tumor clone.

Test Parameters

This test will only detect rearrangements in the 60-70% of follicular lymphomas that have t(14;18) chromosomal fusion in the major breakpoint region (mbr). Test values are expressed as a percentage of mbr fusion product to the amount of DNA control, cyclophilin. Sensitivity of the test is approximately one IGH/BCL2-bearing cell in 10,000 total cells. Levels detected in peripheral blood and bone marrow samples are generally equivalent.

Turnaround Time

Five to seven working days

Sample Requirements

10 ml peripheral blood in purple top tube (EDTA Vacutainer), sent on wet ice

or

2-5 ml of bone marrow aspirate, sent on wet ice

or

Fresh frozen tissue on dry ice

or

Paraffin-embedded tissue at ambient temperature

Please provide a copy of the corresponding pathology report.

CPT Code

81401

Additional charges may apply for tissue extraction.

The CPT codes provided 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 payer being billed.