IGH-CCND1 Fusion, t(11;14) by FISH
Also known as: IGHCC_FISH
Use
The IGH-CCND1 Fusion test, performed using fluorescence in situ hybridization (FISH), is designed to detect the IGH-CCND1 fusion associated with the translocation t(11;14)(q13;q32). This genetic abnormality is primarily found in mantle cell lymphoma but is also observed in other B-cell lymphoproliferative disorders, including plasma cell neoplasms. The test aids in diagnosing these conditions, particularly if cyclin testing is noninformative. A positive result indicates the presence of fused signals in 21 percent or more of the cells evaluated, which is consistent with the IGH-CCND1 fusion.
Special Instructions
Include a surgical pathology report with the specimen. If sending multiple specimens, provide instructions for the pathologist to choose the most appropriate specimen or submit individual orders for each sample. A Pathologist Block Selection Fee may be added.
Limitations
This test was developed and its performance characteristics were determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. The test is expected to detect 95 percent of IGH-CCND1 rearrangements, except for rare instances of cryptic rearrangements. It should be noted that the results are meant to be correlated with clinical, morphologic, and immunophenotypic data. Specimens should not be decalcified and should be fixed in 10 percent neutral buffered formalin only.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 81304-8
- 78236-7
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Tumor Tissue (FFPE)
Volume
Not provided
Minimum Volume
2 slides
Container
paraffin block or 5 unstained (3-micron thick sections) positively charged slides
Storage Instructions
Transport at room temperature; refrigerate during summer months to prevent heat exposure.
Causes for Rejection
Paraffin block with no tumor tissue remaining, fixation in any fixative other than 10 percent neutral buffered formalin, decalcified specimens.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Indefinitely |
| Refrigerated | Indefinitely |
| Frozen | Unacceptable |