FISH ANALYSIS, CCND1/IGH TRANSLOCATION
Pseudonyms: t(11;14); 11;14 translocation; CCND1-IGH fusion; CCND1-IGH translocation; Mantle Cell Lymphoma; B-prolymphocytic leukemia; Chronic Lymphocytic Leukemia; Multiple Myeloma
TURNAROUND TIME: 7 to 10 days
TESTING METHODOLOGY: Fluorescence in situ hybridization
- Collect: 2 mL bone marrow aspirate in sodium heparin (green); 5 mL peripheral blood in sodium heparin (green) also acceptable
- Minimum Collection: 1 mL bone marrow or 2 mL peripheral blood
- Transport: bone marrow or peripheral blood in sodium heparin (green) at 20-25°C; specimen should arrive in the laboratory within 24 hours of collection
- Stability: Ambient: 24 hours; Refrigerated: 24 hours; Frozen: unacceptable
- Unacceptable Conditions: Frozen or clotted specimens; paraffin-embedded specimens; specimens; in anticoagulants other than sodium heparin
Test Summary: Test can detect the 11;14 translocation observed in some cases of B-cell lymphocytic disorders
Methods: A dual-color dual-fusion FISH analysis performed on interphase cells using a probe for the cyclin D1 (CCND1) gene on chromosome 11q13 and a probe for the immunoglobulin heavy chain (IGH) gene on chromosome 14q32; analysis of 200 interphase cells; analysis of 500 interphase cells for minimal residual disease assessment.
Interpretation: A positive result (CCND1/IGH fusion) is reported when the percent of cells with an abnormality exceeds the normal reference range for the probes. The detection of an abnormal clone indicates the presence of an abnormal clone with the 11;14 translocation. A negative result indicates no 11;14 translocation was observed but does not rule out the presence of a neoplastic disorder.
FDA Approval: This test is not approved by the FDA and it should used as an adjunct to other clinical and pathological information.
Indications for Use:
- Detection of an abnormal clone in patients with B-cell lymphocyte disorders such as mantle cell lymphoma, B-prolymphocytic leukemia, splenic lymphoma with villous lymphocytes, CLL and multiple myeloma
- Monitor the response to therapy using the 11;14 translocation (CCND1/IGH fusion)
- Detection of minimal residual disease in patients with a 11;14 translocation