FISH, IGH/BCL3, t(14;19)

Test Code

13617

CPT Codes
88271 (x2), 88275

Includes

If results are not possible from the submitted specimen, the test order will be cancelled and replaced by non-orderable test Cytogenetics Communication.

Preferred Specimen

5 mL whole blood or 3 mL bone marrow collected in a sodium heparin (green-top) tube

Minimum Volume

3 mL whole blood • 1 mL bone marrow

Other Acceptable Specimens

EDTA (lavender-top) tube

Instructions

Clinical history and reason for referral are required with test order. Prior therapy and bone marrow transplant history should be provided with test order.

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

Methodology
Fluorescence in situ Hybridization (FISH)

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

Set up: Daily; Report available: 5 days

Reference Range

See Laboratory Report

Clinical Significance

This test is useful for detecting a neoplastic clone with IGH/BCL3 rearrangement, t(14;19), in patients with Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and other lymphoproliferative neoplasms and tracking response to therapy. CLL/SLL is a mature B cell neoplasm characterized by a progressive accumulation of monoclonal B lymphocytes. CLL/SLL is the most common leukemia in adults in Western countries, accounting for approximately 25-30% of all leukemias in the United States. It is estimated that >21,000 new cases of CLL/SLL will be diagnosed each year in the United States. Approximately 0.9% of all newly diagnosed CLL/SLL patients have IGH/BCL3 translocation. CLL/SLL with t(14;19) has been associated with lymphocytosis, atypical immunophenotype and lymphocyte morphology, unmatured IGHV gene, and an aggressive clinical course.

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.