CLL Panel by FISH : 1001099

Test Code

MDFCPCCLLP or 1001099

Alias/See Also

B-CLL, B-SLL, B-CLL/SLL, B-Chronic lymphocytic leukemia panel

CPT Codes
88271x9, 88275x4

Includes

FISH probes targeting IGH-CCND1 t(11;14); ATM (11q23); Trisomy 12; D13S319 (13q13.4); IGH(14q32.3); TP53 (17p13). Reflex: IGH-BCL2 t(14;18); IGH-BCL3 t(14;19)

If the result for IGH rearrangement is positive and IGH/CCND1 is negative following initial FISH analysis, then the reflex probes will be performed at an additional charge (CPT codes(s): 88271 (x4), 88275 (x2)).

Patient Preparation
Preferred: Sodium heparin (green-top) tube
Alternative Specimen(s): Bone marrow or whole blood collected in: Sodium heparin (royal blue-top) tube or sodium heparin lead-free (tan-top) tube • 5x5 tumor tissue collected in a transport media

Instructions

3 mL bone marrow or 5 mL whole blood collected in a sodium heparin (green-top) tube
Minimum Volume: 1 mL bone marrow • 3 mL whole blood

Transport Container

Blood or Bone Marrow: Do not centrifuge.

Transport Temperature

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

Specimen Stability

Blood and Bone Marrow: Ambient: 48 hours; Refrigerated: 48 hours; Frozen: Unacceptable

Methodology
Fluorescence in situ hybridization (FISH)

Setup Schedule

Monday - Friday

Report Available

Up to 7 days

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

See Laboratory Report

Clinical Significance

This assay is useful for prognostic assessment for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). About 80% cases of CLL have cytogenetic abnormalities detected by FISH. About 50% of CLL show del 13q14.3, about 20% trisomy 12 and, less commonly, deletions of 11q22 and 17p13. Deletion of 17p is associated with a poor prognosis and isolated deletion of 13q14.3 is associated with a more favorable clinical outcome. IGH/CCND1 gene rearrangement helps in establishing the differential diagnosis of mantle cell lymphoma in CD5+ neoplasms. IGH/BCL2 and IGH/BCL3 rearrangements in B-CLL have a distinct mutational profile from the majority of CLLs, providing prognostic value and assisting in risk-stratification.

Performing Laboratory
med fusion

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.